Medical Device Manufacturer · US , Mchenry , IL

Boehringer Mannheim Corp.

340 submissions · 340 cleared · Since 1976
340
Total
340
Cleared
0
Denied

Boehringer Mannheim Corp. — FDA 510(k) Submissions

Boehringer Mannheim Corp. has submitted 340 FDA 510(k) premarket notifications since 1976, of which 340 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Glucose Oxidase, Glucose, Multi-analyte Controls, All Kinds (assayed), Analyzer, Chemistry (photometric, Discrete), For Clinical Use, Glucose Dehydrogenase, Glucose . Use the specialty filter in the sidebar to narrow results.

340 devices
1–25 of 340
ELECYS IGE ASSAY
K984326 · JHR Radioimmunoassay,... · Immunology
Feb 1999 67d
ACCU-CHEK HQ SYSTEM
K983047 · LFR Glucose Dehydrogenase,... · Chemistry
Feb 1999 157d
ELECSYS IGE CALCHECK
K984419 · JJY Multi-analyte Controls,... · Immunology
Feb 1999 54d
MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
K984425 · JIX Calibrator, Multi-analyte... · Chemistry
Jan 1999 40d
ELECSYS CALCHECK TROPONIN T
K984372 · JJY Multi-analyte Controls,... · Chemistry
Dec 1998 7d
ELECSYS TROPONIN T STAT TEST
K984105 · MMI Immunoassay Method,... · Chemistry
Dec 1998 21d
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347
K983503 · CEO Phosphomolybdate... · Chemistry
Dec 1998 56d
PRECISET SERUM PROTEINS CALIBRATOR
K983469 · JIX Calibrator, Multi-analyte... · Chemistry
Nov 1998 55d
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
K983185 · DGC Ige, Antigen, Antiserum,... · Immunology
Nov 1998 62d
ELECSYS PSA, MODEL # ELECSYS 1010
K982948 · LTJ Prostate-specific Antigen... · Immunology
Oct 1998 67d
ELECSYS PSA, MODEL 2010
K982949 · LTJ Prostate-specific Antigen... · Immunology
Oct 1998 67d
CHEMSTRIP 101 URINE ANALYZER
K983510 · KQO Automated Urinalysis System · Chemistry
Oct 1998 20d
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
K983416 · JGJ Photometric Method,... · Chemistry
Oct 1998 22d
TINAQUANT B 2-MICROGLOBULIN ASSAY
K980724 · JZG System, Test,... · Immunology
Oct 1998 234d
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
K983492 · JJY Multi-analyte Controls,... · Chemistry
Oct 1998 4d
ELECSYS MYOGLOBIN STAT ASSAY
K983176 · DDR Myoglobin, Antigen,... · Immunology
Sep 1998 14d
ELECSYS CALCHECK MYOGLOBIN
K983166 · JJY Multi-analyte Controls,... · Chemistry
Sep 1998 12d
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
K982089 · LFR Glucose Dehydrogenase,... · Chemistry
Sep 1998 80d
ACCU-CHEK COMFORT CURVE TEST STRIP
K982002 · LFR Glucose Dehydrogenase,... · Chemistry
Sep 1998 86d
ACCU-CHECK VOICEMATE
K982079 · LFR Glucose Dehydrogenase,... · Chemistry
Aug 1998 74d
B2-MICROGLOBULIN CONTROL SET SERUM
K982471 · JJX Single (specified)... · Chemistry
Aug 1998 21d
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
K981883 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jul 1998 39d
ELECSYS CEA ON THE ELECSYS 1010
K980887 · DHX System, Test,... · Immunology
Jun 1998 112d
CEDIA DAU EDDP ASSAY
K980746 · DJR Enzyme Immunoassay,... · Toxicology
May 1998 89d
ACCU-CHEK COMFORT CURVE TEST STRIPS
K980731 · LFR Glucose Dehydrogenase,... · Chemistry
May 1998 86d

Looking for a specific device from Boehringer Mannheim Corp.? Search by device name or K-number.

Search all Boehringer Mannheim Corp. devices
Filters