Medical Device Manufacturer · US , Mchenry , IL

Kallestad Laboratories, Inc. - FDA 510(k) Cleared Devices

92 submissions · 92 cleared · Since 1976
92
Total
92
Cleared
0
Denied
92 devices
51-75 of 92
Cleared Oct 23, 1980
ANTISERA TO HUMAN FREE KAPPA CHAINS
K802283 · DFH
Immunology · 34d
Cleared Oct 23, 1980
ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.
K802284 · CZQ
Immunology · 34d
Cleared Feb 22, 1980
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
K792610 · DBL
Immunology · 66d
Cleared May 15, 1979
ASSAY REAGENTS, LSA 290
K790588 · JEW
Immunology · 49d
Cleared Apr 04, 1979
RADIOASSAY, CONTROL SERUM I, II, III
K790298 · DGR
Immunology · 51d
Cleared Feb 16, 1979
ANTISERA, RHODAMINE CONJUGATED FRAGMENT
K781951 · DCE
Immunology · 87d
Cleared Feb 08, 1979
RIA KIT, QUANTITOPE IGE
K781904 · DGC
Immunology · 87d
Cleared Jan 26, 1979
RIA KIT, QUANTITOPE CORTISOL
K781903 · CGR
Chemistry · 74d
Cleared Jan 17, 1979
PROCESSOR, K750 COMPUTER/DATA
K782052 · JQP
Chemistry · 41d
Cleared Jan 03, 1979
RIA KIT, QUANTITOPE T3 UPTAKE
K781905 · KHQ
Chemistry · 51d
Cleared Dec 04, 1978
DILUTER, LSA 290 PIPETTER
K781883 · JQW
Chemistry · 27d
Cleared Sep 07, 1978
FLUORESCENT ANTI-NATIVE DNA TEST
K780899 · DHN
Immunology · 97d
Cleared May 03, 1978
QUANTITOPE 125I-FOLATE RADIOASSAY KIT
K780508 · CGN
Chemistry · 34d
Cleared Apr 06, 1978
NEPHELOMETER
K780251 · JQX
Chemistry · 51d
Cleared Mar 17, 1978
QUANTITOPE 125-I GENTAMICIN RIA KIT
K780323 · DJB
Immunology · 18d
Cleared Feb 28, 1978
HEMOPEXIN NEPHELOMETRIC ASSAYS
K780250 · CZX
Immunology · 14d
Cleared Jan 05, 1978
CERULOPLASMIN NEPHEL. ASSAY
K772255 · DDB
Immunology · 27d
Cleared Jan 05, 1978
FLUORESCEIN CONJUG. FRACT. MONO. ANTI.
K772345 · DCB
Microbiology · 13d
Cleared Dec 22, 1977
HAPTOGLOBIN NEPHELOMETRIC ASSAY
K772245 · DAD
Immunology · 13d
Cleared Dec 22, 1977
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY
K772246 · DEB
Immunology · 13d
Cleared Dec 22, 1977
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K772247 · DBI
Immunology · 13d
Cleared Dec 22, 1977
ALBUMIN NEPHELOMETRIC ASSAY
K772248
Immunology · 13d
Cleared Dec 22, 1977
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K772249 · CEW
Immunology · 13d
Cleared Dec 22, 1977
ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY
K772250 · DEI
Immunology · 13d
Cleared Dec 22, 1977
IMMUNOGLOBULIN A NEPHEL. ASSAY
K772251 · CZP
Immunology · 13d

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