Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
FDA 510(k) cleared devices by Boehringer Mannheim Corp. Hematology ✕
15 devices
Cleared
May 13, 1998
ACCU-CHEK A1C HEMOGLOBIN TEST
Hematology
166d
Cleared
Jan 09, 1998
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
Hematology
32d
Cleared
Apr 22, 1997
COAGUCHEK PST SYSTEM
Hematology
295d
Cleared
Nov 21, 1995
COAGUCHEK SYSTEM
Hematology
166d
Cleared
May 11, 1995
COAGUCHEK SYSTEM
Hematology
328d
Cleared
Oct 11, 1994
TINA-QUANT HEMOGLOBIN A1C
Hematology
417d
Cleared
Dec 06, 1993
REFLOTRON HEMOGLOBIN TEST TABS
Hematology
159d
Cleared
Aug 05, 1993
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
Hematology
190d
Cleared
Dec 02, 1991
FRUCTOSAMINE ABG21 TEST SYSTEM
Hematology
111d
Cleared
Jul 05, 1985
PRECINORM HB
Hematology
50d
Cleared
Mar 26, 1982
CYANMETHEMOGLOBIN TEST
Hematology
22d
Cleared
May 03, 1978
HEMO FEC
Hematology
84d
Cleared
Apr 18, 1978
SINGLE VIAL LACTATE
Hematology
11d
Cleared
Oct 08, 1976
BIOTROL-ABNORMAL
Hematology
31d
Cleared
Oct 08, 1976
BIOTROL-NORMAL
Hematology
31d