Medical Device Manufacturer · US , Mchenry , IL

Beckman Instruments, Inc.

281 submissions · 281 cleared · Since 1976
281
Total
281
Cleared
0
Denied

Beckman Instruments, Inc. — FDA 510(k) Submissions

Beckman Instruments, Inc. has submitted 281 FDA 510(k) premarket notifications since 1976, of which 281 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Analyzer, Chemistry (photometric, Discrete), For Clinical Use, Calibrator, Multi-analyte Mixture, Enzymatic Esterase--oxidase, Cholesterol, Counter (beta, Gamma) For Clinical Use . Use the specialty filter in the sidebar to narrow results.

281 devices
1–25 of 281
ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469
K973448 · LGD Enzyme Linked... · Microbiology
Sep 1998 371d
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K982250 · CEC Radioimmunoassay, Free... · Chemistry
Jul 1998 18d
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
K981403 · DKB Calibrators, Drug Mixture · Toxicology
May 1998 21d
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
K981354 · LOJ Kit,... · Immunology
May 1998 17d
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
K980173 · JHI Visual, Pregnancy Hcg,... · Chemistry
Mar 1998 57d
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974816 · LTJ Prostate-specific Antigen... · Immunology
Feb 1998 59d
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
K974564 · DEB Alpha-2-macroglobulin,... · Immunology
Feb 1998 74d
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
K974110 · JBQ Antithrombin Iii... · Hematology
Dec 1997 54d
VIGIL LIPID CONTROL
K974452 · JJY Multi-analyte Controls,... · Chemistry
Dec 1997 22d
BECKMAN CALIBRATOR 2 (CAL2)
K973932 · JIX Calibrator, Multi-analyte... · Chemistry
Dec 1997 61d
BECKMAN URINE PROTEIN CALIBRATOR (UCAL)
K973928 · JIX Calibrator, Multi-analyte... · Chemistry
Dec 1997 47d
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
K973696 · LCP Assay, Glycosylated... · Hematology
Nov 1997 59d
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
K974050 · DCK C-reactive Protein,... · Immunology
Nov 1997 31d
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
K973813 · JZG System, Test,... · Immunology
Nov 1997 44d
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K974075 · MMI Immunoassay Method,... · Chemistry
Nov 1997 12d
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973743 · CHP Radioimmunoassay, Estradiol · Chemistry
Oct 1997 30d
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973966 · CDP Radioimmunoassay, Total... · Chemistry
Oct 1997 14d
SYNCHRON SYSTEMS METHADONE REAGENT
K973069 · DJR Enzyme Immunoassay,... · Toxicology
Sep 1997 35d
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
K971958 · DDG Transferrin, Antigen,... · Immunology
Aug 1997 84d
VIGIL TDM CONTROLS
K972819 · DIF Drug Mixture Control... · Toxicology
Aug 1997 15d
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602 · DHR System, Test, Rheumatoid... · Immunology
Jun 1997 57d
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
K964842 · CZW Complement C3, Antigen,... · Immunology
Jun 1997 190d
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505 · CHH Enzymatic... · Chemistry
Jun 1997 47d
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
K970905 · CHI Lipase-esterase,... · Chemistry
Jun 1997 84d
SYNCHRON SYSTEMS CAL 5 PLUS
K971283 · JIX Calibrator, Multi-analyte... · Immunology
Jun 1997 57d

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