Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
340 devices
Cleared
May 14, 1987
PRECIMAT(R) TRANSFERRIN
Immunology
59d
Cleared
May 14, 1987
PRECIMAT(R) C4
Immunology
59d
Cleared
May 06, 1987
PRECIMAT(R) CRP
Immunology
50d
Cleared
Apr 07, 1987
MODIFICATION OF ACCU-CHEK II
Chemistry
210d
Cleared
Mar 24, 1987
TINA-QUANT(R) (A) C3
Immunology
15d
Cleared
Mar 24, 1987
TINA-QUANT(R) (A) C4
Immunology
15d
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
Oct 29, 1986
ENZYMUN-TEST(R) IGE
Immunology
29d
Cleared
Sep 17, 1986
PRECIMAT (R) IGA, G, M
Immunology
19d
Cleared
Sep 08, 1986
TINA-QUANT(R) IGM
Immunology
48d
Cleared
Sep 04, 1986
TINA-QUANT(R) IGA
Immunology
44d
Cleared
Sep 03, 1986
TINA-QUANT(R) IGG
Immunology
43d
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
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