Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
FDA 510(k) cleared devices by Boehringer Mannheim Corp. Toxicology ✕
23 devices
Cleared
May 26, 1998
CEDIA DAU EDDP ASSAY
Toxicology
89d
Cleared
Apr 21, 1998
CEDIA DAU MULTI-DRUG CALIBRATORS
Toxicology
47d
Cleared
Oct 10, 1997
ELECSYS DIGOXIN
Toxicology
51d
Cleared
Sep 22, 1997
MODIFIED CEDIA DAU PCP ASSAY
Toxicology
42d
Cleared
Jul 24, 1997
CEDIA DIGOXIN CALIBRATORS
Toxicology
24d
Cleared
May 21, 1997
CEDIA DIGOXIN II
Toxicology
72d
Cleared
May 14, 1997
CEDIA DIGOXIN
Toxicology
65d
Cleared
Jan 17, 1997
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
Toxicology
25d
Cleared
Dec 10, 1996
CEDIA DAU BENZODIAZEPINE ASSAY
Toxicology
148d
Cleared
Nov 20, 1996
CEDIA PHENYTOIN II ASSAY
Toxicology
57d
Cleared
Oct 30, 1996
CEDIA DAU OPIATE 2K ASSAY
Toxicology
104d
Cleared
Oct 29, 1996
CEDIA CARDIAC TDM MULTI-CALS
Toxicology
138d
Cleared
Oct 29, 1996
CEDIA N-ACETYLPROCAINAMIDE ASSAY
Toxicology
68d
Cleared
Sep 10, 1996
CEDIA ANTIBIOTIC TDM MULTI-CALS
Toxicology
26d
Cleared
Aug 27, 1996
CEDIA PROCAINAMIDE ASSAY
Toxicology
90d
Cleared
Jun 27, 1996
CEDIA THEOPHYLLINE ASSAY
Toxicology
71d
Cleared
Jun 13, 1996
CEDIA CORE TDM MULTI-CAL
Toxicology
44d
Cleared
Mar 06, 1996
FRONTLINE COCAINE
Toxicology
161d
Cleared
Mar 06, 1996
FRONTLINE CANNABIS
Toxicology
161d
Cleared
Mar 06, 1996
FRONTLINE OPIATES
Toxicology
161d
Cleared
Aug 24, 1995
BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
Toxicology
64d
Cleared
May 31, 1990
ENZYMUN TEST(R) DIGOXIN
Toxicology
78d
Cleared
May 18, 1978
SINGLE VIAL 10 SGOT-TRIS
Toxicology
31d