Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
51 devices
Cleared
Mar 06, 1997
ELECSYS CALCHECK PSA
Immunology
28d
Cleared
Mar 06, 1997
ELECSYS CALCHECK CEA
Immunology
28d
Cleared
Feb 09, 1996
BOEHRINGER MANNHEIM IGG ASSAY
Immunology
42d
Cleared
Feb 09, 1996
BOEHRINGER MANNHEIM IGA ASSAY
Immunology
42d
Cleared
Feb 09, 1996
BOEHRINGER MANNHEIM IGM ASSAY
Immunology
42d
Cleared
Nov 03, 1993
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
Immunology
100d
Cleared
Mar 10, 1993
TINA-QUANT CRP
Immunology
30d
Cleared
Sep 05, 1990
PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
Immunology
111d
Cleared
Jan 18, 1990
LD-1
Immunology
9d
Cleared
Jan 10, 1990
ENZYMUN TEST R IGE
Immunology
33d
Cleared
Jun 15, 1987
TINA-QUANT [A] CRP
Immunology
31d
Cleared
Jun 15, 1987
TINA-QUANT [A] TRANSFERRIN
Immunology
31d
Cleared
May 15, 1987
PRECIMAT(R) C3
Immunology
60d
Cleared
May 15, 1987
PRECINORM(R) PROTEIN
Immunology
60d
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
Mar 24, 1987
TINA-QUANT(R) (A) C3
Immunology
15d
Cleared
Mar 24, 1987
TINA-QUANT(R) (A) C4
Immunology
15d
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
Mar 28, 1986
ENZYMUN-TEST FERRITIN
Immunology
73d