Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
340 devices
Cleared
Oct 23, 1989
URIC ACID PAP
Chemistry
33d
Cleared
Aug 28, 1989
CK-MB/LD-1 CONTROL SYSTEM
Chemistry
70d
Cleared
Jul 20, 1989
PANCREATIC A-AMYLASE PNP
Chemistry
93d
Cleared
Jun 16, 1989
IRON SYSTEM PACK REAGENTS
Chemistry
59d
Cleared
Jun 09, 1989
BICARBONATE
Chemistry
73d
Cleared
Jan 03, 1989
-AMYLASE EPS
Chemistry
222d
Cleared
Dec 09, 1988
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
Chemistry
92d
Cleared
Jul 12, 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
Chemistry
67d
Cleared
Jun 07, 1988
BUN (KINETIC)
Chemistry
49d
Cleared
Mar 24, 1988
TOTAL IRON BINDING CAPACITY (TIBC)
Chemistry
44d
Cleared
Mar 24, 1988
UNIMETER CALIBRATION KIT
Chemistry
41d
Cleared
Jan 21, 1988
PYRIDOXAL-5-PHOSPHATE TABLETS
Chemistry
58d
Cleared
Jan 05, 1988
REFLOTRON (R) AMYLASE
Chemistry
47d
Cleared
Nov 23, 1987
REFLOTRON BILIRUBIN
Chemistry
130d
Cleared
Nov 23, 1987
PRECINORM L
Chemistry
39d
Cleared
Nov 23, 1987
BICARBONATE
Chemistry
26d
Cleared
Oct 19, 1987
URIC ACID PAP
Chemistry
59d
Cleared
Aug 28, 1987
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
Chemistry
24d
Cleared
Aug 18, 1987
SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA)
Chemistry
64d
Cleared
Jul 09, 1987
HITACHI 717 CHEMISTRY ANALYZER
Chemistry
15d
Cleared
Jun 15, 1987
TINA-QUANT [A] CRP
Immunology
31d
Cleared
Jun 15, 1987
TINA-QUANT [A] TRANSFERRIN
Immunology
31d
Cleared
May 26, 1987
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
Chemistry
18d
Cleared
May 15, 1987
PRECIMAT(R) C3
Immunology
60d
Cleared
May 15, 1987
PRECINORM(R) PROTEIN
Immunology
60d
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