Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
245 devices
Cleared
Jul 17, 1991
LINEARITY TEST KITS
Chemistry
44d
Cleared
Jul 17, 1991
ISE/CI-
Chemistry
30d
Cleared
Jul 17, 1991
ISE/NA+
Chemistry
30d
Cleared
Jul 15, 1991
ISE/K+
Chemistry
28d
Cleared
Apr 12, 1991
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
Chemistry
175d
Cleared
Apr 08, 1991
ENZYMUN-TEST PROGESTERONE
Chemistry
48d
Cleared
Nov 06, 1990
REFLOTRON POTASSIUM TEST TABS
Chemistry
67d
Cleared
Oct 22, 1990
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
Chemistry
33d
Cleared
Oct 15, 1990
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
Chemistry
34d
Cleared
Sep 27, 1990
REFLOTRON CREATINE KINASE TEST TABS
Chemistry
21d
Cleared
Sep 07, 1990
REFLOTRON CREATININE TEST TABS
Chemistry
31d
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 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
Looking for a specific device from Boehringer Mannheim Corp.? Search by device name or K-number.
Search all Boehringer Mannheim Corp. devices