Kallestad Diag, A Div. of Erbamont, Inc. - FDA 510(k) Cleared Devices
58
Total
58
Cleared
0
Denied
40 devices
Cleared
Feb 10, 1988
QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK
Immunology
48d
Cleared
Feb 10, 1988
QM2/QM300 CONTROL B PACK
Immunology
48d
Cleared
Jan 22, 1988
QM300 KAPPA LIGHT CHAINS ANTIBODY PACK
Immunology
37d
Cleared
Jan 22, 1988
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
Immunology
37d
Cleared
Oct 07, 1987
QM300 TRANSFERRIN ANTIBODY PACK
Immunology
20d
Cleared
Jul 23, 1987
QM300 C4 ANTIBODY PACK
Immunology
21d
Cleared
Jul 21, 1987
QM300 HAPTOGLOBIN ANTIBODY PACK
Immunology
11d
Cleared
Jul 09, 1987
KALLESTAD QM300 IGM ANTIBODY PACK
Immunology
29d
Cleared
Jun 12, 1987
QM300 C3 ANTIBODY PACK
Immunology
25d
Cleared
Jun 12, 1987
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
Immunology
25d
Cleared
May 21, 1987
QM300 CALIBRATOR A PACK
Immunology
49d
Cleared
May 21, 1987
QM2/QM300 CONTROL A PACK
Immunology
49d
Cleared
May 15, 1987
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM
Immunology
43d
Cleared
May 15, 1987
QM2/QM300 BUFFER AND DILUENT PACK
Immunology
43d
Cleared
Apr 22, 1987
QM300 IGG ANTIBODY PACK
Immunology
20d