Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
245 devices
Cleared
Jul 09, 1987
HITACHI 717 CHEMISTRY ANALYZER
Chemistry
15d
Cleared
May 26, 1987
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
Chemistry
18d
Cleared
Apr 07, 1987
MODIFICATION OF ACCU-CHEK II
Chemistry
210d
Cleared
Feb 26, 1987
ISE COMPENSATION SERA
Chemistry
28d
Cleared
Feb 18, 1987
REFLOTRON(R) AST (GOT)
Chemistry
28d
Cleared
Dec 08, 1986
TRACKER SYSTEM
Chemistry
271d
Cleared
Dec 04, 1986
REFLOTRON(R) ALT (GPT)
Chemistry
45d
Cleared
Aug 19, 1986
ENZYMUN-TEST HCG
Chemistry
77d
Cleared
Jul 29, 1986
TWIN GOT-AST IFCC/GPT-ALT IFCC
Chemistry
81d
Cleared
Jul 11, 1986
REFLOTRON URIC ACID
Chemistry
59d
Cleared
Jul 01, 1986
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704
Chemistry
57d
Cleared
Jun 30, 1986
ENZYMUN TEST TBG
Chemistry
27d
Cleared
Jun 27, 1986
TWIN BUN/GLUCOSE
Chemistry
50d
Cleared
Jun 27, 1986
TWIN TRIGLYCERIDES GPO/CHOLESTEROL
Chemistry
49d
Cleared
Apr 17, 1986
ES600 IMMUNOASSAY SYSTEM
Chemistry
56d
Cleared
Apr 17, 1986
HITACHI 736
Chemistry
49d
Cleared
Apr 03, 1986
PRECINORM IM AND PRECIPATH IM
Chemistry
22d
Cleared
Jan 17, 1986
CREATININE PAP
Chemistry
51d
Cleared
Jan 17, 1986
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
Chemistry
18d
Cleared
Nov 19, 1985
ES 22
Chemistry
29d
Cleared
Nov 12, 1985
IRON
Chemistry
18d
Cleared
Oct 28, 1985
HITACHI 704
Chemistry
28d
Cleared
Sep 16, 1985
REFLOTRON SYSTEM
Chemistry
123d
Cleared
Aug 01, 1985
ACCU-CHEK II
Chemistry
112d
Cleared
Mar 12, 1985
UROTRON RL9
Chemistry
43d
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