Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
340 devices
Cleared
Aug 05, 1993
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
Hematology
190d
Cleared
Jun 15, 1993
CHEMSTRIP URINE ANALYZER
Chemistry
75d
Cleared
Mar 10, 1993
TINA-QUANT CRP
Immunology
30d
Cleared
Oct 14, 1992
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
Chemistry
112d
Cleared
Oct 13, 1992
ACCUDATA GLUCOSE TEST STATION
Chemistry
40d
Cleared
Jun 30, 1992
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
Chemistry
84d
Cleared
Mar 24, 1992
CHEMSTRIP URINE ANALYZER
Chemistry
18d
Cleared
Feb 14, 1992
ENZYMUN-TEST TSH
Chemistry
87d
Cleared
Dec 09, 1991
CEDIA T4
Chemistry
20d
Cleared
Dec 02, 1991
FRUCTOSAMINE ABG21 TEST SYSTEM
Hematology
111d
Cleared
Sep 27, 1991
ENZYMUN-TEST ESTRADIOL
Chemistry
72d
Cleared
Sep 13, 1991
URINARY/CSF PROTEIN
Chemistry
31d
Cleared
Aug 28, 1991
PROACT CHOLESTEROL SYSTEMS
Chemistry
100d
Cleared
Aug 12, 1991
REFLOTRON CREATININE TEST TABS
Chemistry
31d
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
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