Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
340 devices
Cleared
Jan 30, 1997
ELECSYS CALCHECK TESTOSTERONE
Chemistry
15d
Cleared
Jan 24, 1997
ELECSYS LH ASSAY
Chemistry
63d
Cleared
Jan 21, 1997
ELECSYS PROLACTIN ASSAY
Chemistry
56d
Cleared
Jan 17, 1997
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1
Toxicology
25d
Cleared
Dec 16, 1996
ELECSYS FT3
Chemistry
126d
Cleared
Dec 16, 1996
ELECSYS FSH ASSAY
Chemistry
24d
Cleared
Dec 16, 1996
ELECSYS CALCHECK FSH
Chemistry
14d
Cleared
Dec 16, 1996
ELECSYS CALCHECK LH
Chemistry
14d
Cleared
Dec 10, 1996
CEDIA DAU BENZODIAZEPINE ASSAY
Toxicology
148d
Cleared
Nov 29, 1996
ENZYMUN-TEST FT3
Chemistry
136d
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
Oct 23, 1996
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
Chemistry
68d
Cleared
Sep 10, 1996
ELECSYS CALCHECK T UPDATE
Chemistry
27d
Cleared
Sep 10, 1996
CEDIA ANTIBIOTIC TDM MULTI-CALS
Toxicology
26d
Cleared
Aug 30, 1996
ELECSYS CALCHECK HCG
Chemistry
16d
Cleared
Aug 27, 1996
CEDIA PROCAINAMIDE ASSAY
Toxicology
90d
Cleared
Aug 27, 1996
ELECSYS CALCHECK FT3
Chemistry
13d
Cleared
Aug 27, 1996
ELECSYS CALCHECK FT4
Chemistry
13d
Cleared
Aug 27, 1996
ELECYS CALCHECK T 3
Chemistry
13d
Cleared
Aug 27, 1996
ELECSYS CALCHECK T4
Chemistry
13d
Cleared
Aug 23, 1996
ELECSYS CALCHECK TROPONIN T
Chemistry
10d
Cleared
Aug 23, 1996
ELECSYS CALCHECK TSH
Chemistry
10d
Looking for a specific device from Boehringer Mannheim Corp.? Search by device name or K-number.
Search all Boehringer Mannheim Corp. devices