Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

92 results for "Kallestad Laboratories, Inc."
49–72 of 92
Search insights Median review: 28d Cleared: 100% Top manufacturer: Kallestad Laboratories, Inc. Lead specialty: Immunology
Cleared May 29, 1981
KALLESTAD ANTISERA TO PHENOBARBITAL
K811367 · DLZ
Kallestad Laboratories, Inc.
Chemistry · 15d
Cleared Apr 14, 1981
KALLESTAD HEP-2 CELL LINE SUBSTRATE
K810863 · DBM
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Oct 23, 1980
ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.
K802284 · CZQ
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Oct 23, 1980
ANTISERA TO HUMAN FREE KAPPA CHAINS
K802283 · DFH
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Feb 22, 1980
KALLESTAD FLORESCENT ANA/AMA/ASMA TEST
K792610 · DBL
Kallestad Laboratories, Inc.
Immunology · 66d
Cleared May 15, 1979
ASSAY REAGENTS, LSA 290
K790588 · JEW
Kallestad Laboratories, Inc.
Immunology · 49d
Cleared Apr 04, 1979
RADIOASSAY, CONTROL SERUM I, II, III
K790298 · DGR
Kallestad Laboratories, Inc.
Immunology · 51d
Cleared Feb 16, 1979
ANTISERA, RHODAMINE CONJUGATED FRAGMENT
K781951 · DCE
Kallestad Laboratories, Inc.
Immunology · 87d
Cleared Feb 08, 1979
RIA KIT, QUANTITOPE IGE
K781904 · DGC
Kallestad Laboratories, Inc.
Immunology · 87d
Cleared Jan 26, 1979
RIA KIT, QUANTITOPE CORTISOL
K781903 · CGR
Kallestad Laboratories, Inc.
Chemistry · 74d
Cleared Jan 17, 1979
PROCESSOR, K750 COMPUTER/DATA
K782052 · JQP
Kallestad Laboratories, Inc.
Chemistry · 41d
Cleared Jan 03, 1979
RIA KIT, QUANTITOPE T3 UPTAKE
K781905 · KHQ
Kallestad Laboratories, Inc.
Chemistry · 51d
Cleared Dec 04, 1978
DILUTER, LSA 290 PIPETTER
K781883 · JQW
Kallestad Laboratories, Inc.
Chemistry · 27d
Cleared Sep 07, 1978
FLUORESCENT ANTI-NATIVE DNA TEST
K780899 · DHN
Kallestad Laboratories, Inc.
Immunology · 97d
Cleared May 03, 1978
QUANTITOPE 125I-FOLATE RADIOASSAY KIT
K780508 · CGN
Kallestad Laboratories, Inc.
Chemistry · 34d
Cleared Apr 06, 1978
NEPHELOMETER
K780251 · JQX
Kallestad Laboratories, Inc.
Chemistry · 51d
Cleared Mar 17, 1978
QUANTITOPE 125-I GENTAMICIN RIA KIT
K780323 · DJB
Kallestad Laboratories, Inc.
Immunology · 18d
Cleared Feb 28, 1978
HEMOPEXIN NEPHELOMETRIC ASSAYS
K780250 · CZX
Kallestad Laboratories, Inc.
Immunology · 14d
Cleared Jan 05, 1978
FLUORESCEIN CONJUG. FRACT. MONO. ANTI.
K772345 · DCB
Kallestad Laboratories, Inc.
Microbiology · 13d
Cleared Jan 05, 1978
CERULOPLASMIN NEPHEL. ASSAY
K772255 · DDB
Kallestad Laboratories, Inc.
Immunology · 27d
Cleared Dec 22, 1977
IMMUNOGLOBULIN M NEPHEL. ASSAY
K772254 · DFT
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
TRANSFERRIN NEPHELOMETRIC ASSAY
K772253 · DDG
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
IMMUNOGLOBULIN G NEPHEL. ASSAY
K772252 · DEW
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Dec 22, 1977
IMMUNOGLOBULIN A NEPHEL. ASSAY
K772251 · CZP
Kallestad Laboratories, Inc.
Immunology · 13d