Kallestad Laboratories, Inc. - FDA 510(k) Cleared Devices
92
Total
92
Cleared
0
Denied
64 devices
Cleared
Dec 02, 1981
QUANTIMETRIC 2 TEST KIT
Immunology
15d
Cleared
Sep 01, 1981
KAPPA & LAMBDA BENCE JONES CONTROLS
Immunology
14d
Cleared
Jul 16, 1981
KALLESTAD'S ENDOPLATE FACTOR B TEST
Immunology
27d
Cleared
Jun 25, 1981
QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.
Immunology
17d
Cleared
Jun 24, 1981
KALLESTAD R QUANTIPLATE ALT. PATHWAY T.
Immunology
33d
Cleared
Apr 14, 1981
KALLESTAD HEP-2 CELL LINE SUBSTRATE
Immunology
14d
Cleared
Oct 23, 1980
ANTISERA TO HUMAN FREE KAPPA CHAINS
Immunology
34d
Cleared
Oct 23, 1980
ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.
Immunology
34d
Cleared
Feb 22, 1980
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
Immunology
66d
Cleared
May 15, 1979
ASSAY REAGENTS, LSA 290
Immunology
49d
Cleared
Apr 04, 1979
RADIOASSAY, CONTROL SERUM I, II, III
Immunology
51d
Cleared
Feb 16, 1979
ANTISERA, RHODAMINE CONJUGATED FRAGMENT
Immunology
87d
Cleared
Feb 08, 1979
RIA KIT, QUANTITOPE IGE
Immunology
87d
Cleared
Sep 07, 1978
FLUORESCENT ANTI-NATIVE DNA TEST
Immunology
97d
Cleared
Mar 17, 1978
QUANTITOPE 125-I GENTAMICIN RIA KIT
Immunology
18d
Cleared
Feb 28, 1978
HEMOPEXIN NEPHELOMETRIC ASSAYS
Immunology
14d
Cleared
Jan 05, 1978
CERULOPLASMIN NEPHEL. ASSAY
Immunology
27d
Cleared
Dec 22, 1977
HAPTOGLOBIN NEPHELOMETRIC ASSAY
Immunology
13d
Cleared
Dec 22, 1977
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY
Immunology
13d
Cleared
Dec 22, 1977
COMPLEMENT C4 NEPHELOMETRIC ASSAY
Immunology
13d
Cleared
Dec 22, 1977
ALBUMIN NEPHELOMETRIC ASSAY
Immunology
13d
Cleared
Dec 22, 1977
COMPLEMENT C3 NEPHELOMETRIC ASSAY
Immunology
13d
Cleared
Dec 22, 1977
ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY
Immunology
13d
Cleared
Dec 22, 1977
IMMUNOGLOBULIN A NEPHEL. ASSAY
Immunology
13d
Cleared
Dec 22, 1977
IMMUNOGLOBULIN G NEPHEL. ASSAY
Immunology
13d