Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
340 devices
Cleared
Dec 26, 1995
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
Chemistry
83d
Cleared
Dec 21, 1995
CEDIA T UPTAKE ASSAY
Chemistry
63d
Cleared
Nov 21, 1995
COAGUCHEK SYSTEM
Hematology
166d
Cleared
Nov 21, 1995
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
Chemistry
155d
Cleared
Nov 09, 1995
BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
Chemistry
163d
Cleared
Oct 26, 1995
CHEMSTRIP MICRAL URINE TEST STRIPS
Chemistry
38d
Cleared
Oct 23, 1995
CHEMSTRIP CRITERION URINE ANALYZER
Chemistry
56d
Cleared
Sep 25, 1995
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
Chemistry
76d
Cleared
Aug 24, 1995
ADVANTAGE TEST STRIPS
Chemistry
122d
Cleared
Aug 24, 1995
BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
Toxicology
64d
Cleared
Aug 11, 1995
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
Chemistry
140d
Cleared
Jul 20, 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
Chemistry
73d
Cleared
May 11, 1995
COAGUCHEK SYSTEM
Hematology
328d
Cleared
Feb 10, 1995
TINA-QUANT MICROALBUMIN
Chemistry
603d
Cleared
Dec 05, 1994
BOEHRINGER MANNHEIM BICARBONATE ASSAY
Chemistry
507d
Cleared
Nov 08, 1994
CHEMSTRIP MINI UA URINE ANALYZER
Chemistry
106d
Cleared
Oct 11, 1994
TINA-QUANT HEMOGLOBIN A1C
Hematology
417d
Cleared
Oct 04, 1994
HITACHI 914 ANALYZER
Chemistry
140d
Cleared
Apr 26, 1994
CARDIAC T ELISA TROPONIN-T
Chemistry
603d
Cleared
Feb 10, 1994
SOFTTOUCH II LANCET DEVICE
General & Plastic Surgery
335d
Cleared
Dec 06, 1993
REFLOTRON HEMOGLOBIN TEST TABS
Hematology
159d
Cleared
Nov 17, 1993
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
Chemistry
162d
Cleared
Nov 03, 1993
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
Immunology
100d
Cleared
Oct 14, 1993
CHEMSTRIP SUPER UA URINE ANALYZER
Chemistry
56d
Cleared
Sep 08, 1993
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
Chemistry
195d
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