Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
245 devices
Cleared
Mar 08, 1982
LD-L TRIS SYSTEM PACK TEST
Chemistry
27d
Cleared
Feb 04, 1982
ELECTROLYTE ANALYZER ACCESSORY
Chemistry
17d
Cleared
Nov 06, 1981
URIC ACID SYSTEM PACK TEST
Chemistry
14d
Cleared
Sep 01, 1981
GLUCOSE-HK SYSTEM PACK TEST
Chemistry
14d
Cleared
Aug 31, 1981
ENXYMATIC CREATININE TEST
Chemistry
38d
Cleared
Aug 31, 1981
FUN-UV SYSTEM PACK TEST
Chemistry
18d
Cleared
Jul 23, 1981
HITACHI 705 CALIBRATOR
Chemistry
21d
Cleared
Jul 15, 1981
PRECINORM U & PRECIPATH U HUMAN SERUM
Chemistry
16d
Cleared
Jun 18, 1981
REAGENT SET TRIGLYCERIDES
Chemistry
16d
Cleared
May 27, 1981
HITACHI 705 AUTOMATIC BLOOD CHEMISTRY
Chemistry
27d
Cleared
Apr 17, 1981
BIO SET TM SUBSTRATE CALIBRATORS
Chemistry
9d
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
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