Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
340 devices
Cleared
Apr 17, 1981
BIO SET TM PHOSPHOROUS CALIBRATOR
Chemistry
9d
Cleared
Feb 23, 1981
ALT (UV) TEST
Chemistry
13d
Cleared
Feb 23, 1981
BICARBONATE TEST
Chemistry
13d
Cleared
Feb 23, 1981
AST (UV) TEST
Chemistry
13d
Cleared
Oct 23, 1980
URIC ACID/ALDH
Chemistry
24d
Cleared
Aug 20, 1980
BMC RIAFLO SYSTEM
Chemistry
57d
Cleared
Mar 19, 1980
RIA PHASE T4
Chemistry
49d
Cleared
Mar 19, 1980
RIA PHASE TBG
Chemistry
49d
Cleared
Mar 19, 1980
RIA PHASE DIGOXIN
Chemistry
49d
Cleared
Dec 18, 1979
STATTEK BUN
Chemistry
29d
Cleared
Nov 27, 1979
SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES
Chemistry
21d
Cleared
Jun 15, 1979
CHEMTAB
Chemistry
56d
Cleared
Mar 02, 1979
UNITEST AMYLASE
Chemistry
86d
Cleared
Mar 02, 1979
UNITEST CREATINE KINASE
Chemistry
70d
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
Aug 10, 1978
ULTRASOUND IMAGING SYSTEM
Radiology
57d
Cleared
May 19, 1978
REAGENT SET HDL CHOLESTEROL
Chemistry
32d
Cleared
May 18, 1978
SINGLE VIAL 10 SGOT-TRIS
Toxicology
31d
Cleared
May 18, 1978
SINGLE VIAL 10 SGPT-TRIS
Chemistry
31d
Cleared
May 03, 1978
HEMO FEC
Hematology
84d
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