Kallestad Diag, A Div. of Erbamont, Inc. - FDA 510(k) Cleared Devices
58
Total
58
Cleared
0
Denied
58 devices
Cleared
Sep 22, 1988
QM300 CALIBRATOR F PACK
Immunology
23d
Cleared
Sep 22, 1988
QM300 CONTROL F PACK
Immunology
23d
Cleared
Sep 07, 1988
QM300 RHEUMATOID FACTOR ANTIGEN PACK
Immunology
20d
Cleared
Sep 07, 1988
QM300 CALIBRATOR E PACK
Immunology
20d
Cleared
Jul 08, 1988
QM300 ALBUMIN ANTIBODY PACK
Immunology
51d
Cleared
Jul 08, 1988
QM300 IGG ANTIBODY PACK
Immunology
51d
Cleared
Jun 06, 1988
KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST
Immunology
27d
Cleared
Apr 21, 1988
QM300 CALIBRATOR D PACK
Immunology
36d
Cleared
Apr 12, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT
Microbiology
42d
Cleared
Apr 06, 1988
QM300 ALBUMIN ANTIBODY PACK
Immunology
21d
Cleared
Mar 30, 1988
KALLESTAD QM300 CALIBRATOR C PACK
Immunology
36d
Cleared
Mar 25, 1988
KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK
Immunology
31d
Cleared
Mar 25, 1988
KALLESTAD QM2/QM300 CONTROL C PACK
Immunology
31d
Cleared
Mar 23, 1988
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
Microbiology
7d
Cleared
Mar 17, 1988
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS
Microbiology
72d
Cleared
Feb 17, 1988
QM300 CALIBRATOR B PACK
Immunology
55d
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