Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
340 devices
Cleared
Aug 23, 1996
ELECSYS CALCHECK CK-MB
Chemistry
9d
Cleared
Aug 15, 1996
ELECSYS T3
Chemistry
49d
Cleared
Jul 26, 1996
CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK)
Chemistry
150d
Cleared
Jul 22, 1996
ELECSYS TSH ASSAY
Chemistry
95d
Cleared
Jul 22, 1996
ELECSYS PRECICONTROL TSH
Chemistry
21d
Cleared
Jul 22, 1996
ELECSYS PRECICONTROL CARDIAC
Chemistry
21d
Cleared
Jun 27, 1996
CEDIA THEOPHYLLINE ASSAY
Toxicology
71d
Cleared
Jun 14, 1996
ELECSYS 2010 ANALYZER
Chemistry
57d
Cleared
Jun 13, 1996
ELECSYS T4 ASSAY
Chemistry
56d
Cleared
Jun 13, 1996
CEDIA CORE TDM MULTI-CAL
Toxicology
44d
Cleared
Jun 12, 1996
ELECSYS HCG ASSAY
Chemistry
55d
Cleared
Jun 12, 1996
ELECSYS T-UPTAKE ASSAY
Chemistry
55d
Cleared
Jun 11, 1996
ELECSYS FT4 ASSAY
Chemistry
54d
Cleared
Jun 11, 1996
ELECSYS TROPONIN T
Chemistry
54d
Cleared
Jun 11, 1996
ELECSYS CK-MB
Chemistry
54d
Cleared
Apr 17, 1996
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
583d
Cleared
Mar 06, 1996
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
Chemistry
541d
Cleared
Mar 06, 1996
FRONTLINE COCAINE
Toxicology
161d
Cleared
Mar 06, 1996
FRONTLINE CANNABIS
Toxicology
161d
Cleared
Mar 06, 1996
FRONTLINE OPIATES
Toxicology
161d
Cleared
Feb 15, 1996
ACCU-CHEK ADVANTAGE TEST STRIPS
Chemistry
118d
Cleared
Feb 14, 1996
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
Chemistry
48d
Cleared
Feb 09, 1996
BOEHRINGER MANNHEIM IGG ASSAY
Immunology
42d
Cleared
Feb 09, 1996
BOEHRINGER MANNHEIM IGA ASSAY
Immunology
42d
Cleared
Feb 09, 1996
BOEHRINGER MANNHEIM IGM ASSAY
Immunology
42d
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