Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
245 devices
Cleared
Aug 27, 1996
ELECYS CALCHECK T 3
Chemistry
13d
Cleared
Aug 27, 1996
ELECSYS CALCHECK T4
Chemistry
13d
Cleared
Aug 23, 1996
ELECSYS CALCHECK TROPONIN T
Chemistry
10d
Cleared
Aug 23, 1996
ELECSYS CALCHECK TSH
Chemistry
10d
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 14, 1996
ELECSYS 2010 ANALYZER
Chemistry
57d
Cleared
Jun 13, 1996
ELECSYS T4 ASSAY
Chemistry
56d
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
Feb 15, 1996
ACCU-CHEK ADVANTAGE TEST STRIPS
Chemistry
118d
Cleared
Feb 14, 1996
BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
Chemistry
48d
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
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
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