Medical Device Manufacturer · US , Newark, , DE

Dade Behring, Inc.

343 submissions · 343 cleared · Since 1978
343
Total
343
Cleared
0
Denied

Dade Behring, Inc. — FDA 510(k) Submissions

Dade Behring, Inc. has submitted 343 FDA 510(k) premarket notifications since 1978, of which 343 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, Calibrator, Secondary, Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, Calibrator, Multi-analyte Mixture, System, Multipurpose For In Vitro Coagulation Studies . Use the specialty filter in the sidebar to narrow results.

343 devices
1–25 of 343
PT-MULTI-CALIBRATOR, MODEL OPAT07
K093848 · GGN Plasma, Coagulation Control · Hematology
Dec 2010 369d
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
K081161 · CFN Method, Nephelometric,... · Immunology
Jul 2008 95d
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
K081249 · DEB Alpha-2-macroglobulin,... · Immunology
Jul 2008 80d
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
K071603 · DHX System, Test,... · Immunology
Jun 2008 379d
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
K071597 · LOJ Kit,... · Immunology
Jun 2008 358d
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
K073604 · CEC Radioimmunoassay, Free... · Chemistry
Mar 2008 83d
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
K073561 · CFN Method, Nephelometric,... · Immunology
Feb 2008 69d
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
K073072 · JHM Colorimetric Method,... · Chemistry
Feb 2008 113d
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055 · JFY Enzymatic Method, Creatinine · Chemistry
Jan 2008 65d
DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON
K072965 · DBA Complement C1 Inhibitor... · Immunology
Dec 2007 60d
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
K072717 · JIT Calibrator, Secondary · Chemistry
Dec 2007 78d
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
K071224 · CDD Radioassay, Vitamin B12 · Chemistry
Nov 2007 195d
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
K072435 · JIX Calibrator, Multi-analyte... · Chemistry
Oct 2007 48d
FIBRINOGEN CALIBRATOR KIT
K072304 · GFX Fibrinogen Standard · Hematology
Sep 2007 33d
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980 · JJY Multi-analyte Controls,... · Immunology
Sep 2007 55d
ETOH FLEX REAGENT CARTRIDGE (DF22)
K071811 · DIC Alcohol Dehydrogenase,... · Toxicology
Aug 2007 52d
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
K071316 · LRG Instrument For Auto... · Microbiology
Aug 2007 102d
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN
K071317 · LON System, Test, Automated,... · Microbiology
Aug 2007 102d
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
K071834 · NBC Test, Natriuretic Peptide · Chemistry
Aug 2007 45d
N LATEX RF KIT
K071247 · DHR System, Test, Rheumatoid... · Immunology
Aug 2007 96d
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
K071767 · NBC Test, Natriuretic Peptide · Chemistry
Aug 2007 36d
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM
K070346 · LON System, Test, Automated,... · Microbiology
Jul 2007 162d
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE
K071268 · LON System, Test, Automated,... · Microbiology
Jun 2007 50d
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
K070853 · DIC Alcohol Dehydrogenase,... · Chemistry
Jun 2007 77d
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
K071076 · LON System, Test, Automated,... · Microbiology
May 2007 35d

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