Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
340 devices
Cleared
Sep 05, 1990
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
Immunology
111d
Cleared
Aug 22, 1990
REDITEST STREP A TEST KIT
Microbiology
34d
Cleared
Aug 09, 1990
REFLOTRON HDL CHOLESTEROL TEST TABS
Chemistry
59d
Cleared
Aug 09, 1990
PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF
Chemistry
59d
Cleared
Jul 10, 1990
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM
Chemistry
33d
Cleared
Jul 10, 1990
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM
Chemistry
33d
Cleared
May 31, 1990
ENZYMUN TEST(R) DIGOXIN
Toxicology
78d
Cleared
May 15, 1990
ENZYMUN TEST(R) FT4 (FREE THYROXINE)
Chemistry
78d
Cleared
May 02, 1990
ENZYMUN TEST(R) CORTISOL
Chemistry
90d
Cleared
Apr 16, 1990
BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER
Chemistry
42d
Cleared
Apr 16, 1990
ES 300 IMMUNOASSAY SYSTEM
Chemistry
24d
Cleared
Apr 11, 1990
ENZYMUN TEST(R) TSH-S
Chemistry
82d
Cleared
Apr 03, 1990
ENZYMUN TEST(R) LH
Chemistry
42d
Cleared
Apr 03, 1990
ENZYMUN TEST(R) INSULIN
Chemistry
22d
Cleared
Mar 30, 1990
ENZYMUN TEST(R) PROLACTIN
Chemistry
45d
Cleared
Mar 30, 1990
ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
Chemistry
21d
Cleared
Mar 15, 1990
ENZYMUN TEST(R) FSH
Chemistry
27d
Cleared
Mar 01, 1990
ENZYMUN TEST(R) TBK
Chemistry
78d
Cleared
Feb 08, 1990
ENZYMUN TEST R T3
Chemistry
62d
Cleared
Feb 08, 1990
ENZYMUN TEST R HCG
Chemistry
62d
Cleared
Jan 18, 1990
LD-1
Immunology
9d
Cleared
Jan 11, 1990
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
Chemistry
63d
Cleared
Jan 10, 1990
ENZYMUN TEST R IGE
Immunology
33d
Cleared
Dec 19, 1989
PANCREATIC A-AMYLASE EPS
Chemistry
75d
Cleared
Oct 27, 1989
BUN (KINETIC)
Chemistry
37d
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