Kallestad Diag, A Div. of Erbamont, Inc. - FDA 510(k) Cleared Devices
58
Total
58
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kallestad Diag, A Div. of Erbamont, Inc. Immunology ✕
40 devices
Cleared
Jun 21, 1990
MODIFIED QM300 RHEUMATOID FACTOR TEST
Immunology
17d
Cleared
Jan 22, 1990
ALLERCOAT MICROPLATE SYSTEM
Immunology
19d
Cleared
Dec 01, 1989
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
Immunology
18d
Cleared
Nov 06, 1989
MODIFIED QM300 ALBUMIN ANTIBODY PACK
Immunology
19d
Cleared
Sep 21, 1989
QM300 CERULOPLASMIN ANTIBODY PACK
Immunology
22d
Cleared
Aug 04, 1989
QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
Immunology
15d
Cleared
Dec 20, 1988
QM300 PCR ANTIBODY PACK
Immunology
19d
Cleared
Nov 04, 1988
QM300 CONTROL E
Immunology
78d
Cleared
Oct 19, 1988
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK
Immunology
50d
Cleared
Oct 19, 1988
QM300 APOLIPOPROTEIN B ANTIBODY PACK
Immunology
50d
Cleared
Sep 22, 1988
QM300 CALIBRATOR D PACK
Immunology
66d
Cleared
Sep 22, 1988
QM300 PREALBUMIN ANTIBODY PACK
Immunology
66d
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