Medical Device Manufacturer · US , Mchenry , IL

Behring Diagnostics, Inc.

145 submissions · 145 cleared · Since 1976
145
Total
145
Cleared
0
Denied

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

Behring Diagnostics, Inc. has submitted 145 FDA 510(k) premarket notifications since 1976, of which 145 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), System, Test, Rheumatoid Factor, Colorimeter, Photometer, Spectrophotometer For Clinical Use, Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, Multi-analyte Controls, All Kinds (assayed) . Use the specialty filter in the sidebar to narrow results.

145 devices
1–25 of 145
OPUS HLH CONTROLS
K973832 · JJX Single (specified)... · Toxicology
Oct 1997 20d
N ANTISERUM TO HUMAN ALBUMIN
K972929 · DCF Albumin, Antigen,... · Immunology
Oct 1997 73d
N ANTISERUM TO HUMAN TRANSFERRIN
K972840 · DDG Transferrin, Antigen,... · Immunology
Oct 1997 77d
MODIFICATION OF OPUS FERRITIN TEST SYSTEM
K973202 · DBF Ferritin, Antigen,... · Immunology
Sep 1997 66d
OPUS D-DIMER
K972316 · GHH Fibrin Split Products · Hematology
Sep 1997 81d
VON WILLEBRAND REAGENT
K972116 · GGP Test, Qualitative And... · Hematology
Jul 1997 50d
OPUS ETHANOL
K972011 · DIC Alcohol Dehydrogenase,... · Toxicology
Jul 1997 53d
EMIT II OPIATES 300/2000 ASSAY
K971596 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jun 1997 55d
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
K971600 · DKB Calibrators, Drug Mixture · Toxicology
Jun 1997 55d
OPUS PSA TEST SYSTEM
K964595 · LTJ Prostate-specific Antigen... · Immunology
Jun 1997 218d
OPUS PROGESTERONE
K971725 · JLS Radioimmunoassay,... · Chemistry
Jun 1997 40d
BC THROMBIN REAGENT
K970645 · GJA Test, Thrombin Time · Hematology
May 1997 88d
BEHRING COAGULATION SYSTEM
K970431 · JPA System, Multipurpose For... · Hematology
May 1997 90d
OPUS BONE ALP
K964764 · CIN Electrophoretic... · Chemistry
Jan 1997 58d
N RHEUMATOLOGY STANDARD SL
K964527 · JIX Calibrator, Multi-analyte... · Immunology
Jan 1997 64d
N LATEX CRP MONO REAGENT
K964687 · DCH System, Test, C-reactive... · Immunology
Dec 1996 90d
PROC APC ASSAY, PROC CONTROL PLASMA
K962968 · GGP Test, Qualitative And... · Hematology
Dec 1996 136d
N PROTEIN STRANDARD SL
K964062 · JIX Calibrator, Multi-analyte... · Chemistry
Nov 1996 42d
N/T PROTEIN CONTROL SL
K964065 · JJY Multi-analyte Controls,... · Chemistry
Nov 1996 27d
OPUS CMV TEST SYSTEM-MODIFICATION
K963084 · LFZ Enzyme Linked... · Microbiology
Oct 1996 62d
N LATEX B2-MICROGLOBULIN REAGENT
K955596 · JZG System, Test,... · Immunology
Oct 1996 300d
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
K962519 · LCD Enzyme Immunoassay,... · Toxicology
Sep 1996 69d
OPUS HLH
K962866 · CEP Radioimmunoassay,... · Chemistry
Aug 1996 31d
OPUS MYOGLOBIN CONTROLS
K962841 · JJX Single (specified)... · Immunology
Aug 1996 24d
N ANTISERUM TO C1 INHIBITOR
K960257 · DBA Complement C1 Inhibitor... · Immunology
Aug 1996 196d

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