Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
245 devices
Cleared
Feb 01, 1979
PREGNANCY TEST KIT, DAISY 2 IN HOME
Chemistry
30d
Cleared
Jan 03, 1979
BILIRUBIN, DINGLE VALVE DPD
Chemistry
51d
Cleared
Dec 20, 1978
UROTRON
Chemistry
86d
Cleared
Dec 20, 1978
CHEMSTRIP CONTROL
Chemistry
77d
Cleared
Oct 03, 1978
SINGLE VIAL LDH-L TRIS
Chemistry
25d
Cleared
Aug 14, 1978
STATTEK-GLUCOSE LOW LEVEL
Chemistry
47d
Cleared
May 19, 1978
REAGENT SET HDL CHOLESTEROL
Chemistry
32d
Cleared
May 18, 1978
SINGLE VIAL 10 SGPT-TRIS
Chemistry
31d
Cleared
Apr 18, 1978
PRECIMAT GLYCEROL
Chemistry
29d
Cleared
Nov 11, 1977
FASTCHEM BUN
Chemistry
29d
Cleared
Oct 25, 1977
CHEMCODE/CHEMTEK SYSTEM
Chemistry
81d
Cleared
Aug 22, 1977
CK-MB
Chemistry
17d
Cleared
Jul 11, 1977
LYTETEK SYSTEM
Chemistry
74d
Cleared
Mar 16, 1977
CHEMSTRIP G
Chemistry
30d
Cleared
Mar 01, 1977
URIC ACID TEST, BMC AUTOFLO
Chemistry
15d
Cleared
Mar 01, 1977
TEST, AMMONIA, BMC REAGENTSET
Chemistry
15d
Cleared
Feb 11, 1977
REFLOMAT/REFLOTEST SYSTEM
Chemistry
77d
Cleared
Jan 26, 1977
BIO TROL-T TRIOLEIN SOLUTIONS
Chemistry
13d
Cleared
Nov 29, 1976
TRIGLYCERIDES TEST
Chemistry
66d
Cleared
Nov 01, 1976
BUN-REATIVE
Chemistry
80d
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