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."
1–24 of 92
Search insights Median review: 28d Cleared: 100% Top manufacturer: Kallestad Laboratories, Inc. Lead specialty: Immunology
Cleared Dec 03, 1986
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681 · LJP
Kallestad Laboratories, Inc.
Microbiology · 75d
Cleared Oct 22, 1986
PATHFINDER ROTAVIRUS CHEMILUMINESCENT
K862917 · LIQ
Kallestad Laboratories, Inc.
Microbiology · 82d
Cleared Oct 10, 1986
PATHFINDER(TM) SPECIMEN COLLECTION KIT
K863682 · JSM
Kallestad Laboratories, Inc.
Microbiology · 21d
Cleared Sep 29, 1986
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743 · GQG
Kallestad Laboratories, Inc.
Microbiology · 70d
Cleared Aug 06, 1986
KALLESTAD SM/RNP TEST REAGENT
K862313 · LKJ
Kallestad Laboratories, Inc.
Immunology · 49d
Cleared Jul 29, 1986
KALLESTAD SSA/SSB ENA TEST REAGENTS
K862710 · LLL
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Mar 14, 1986
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
K855014 · JIX
Kallestad Laboratories, Inc.
Immunology · 88d
Cleared Feb 28, 1986
QUANTIMETRIC PLUS IGM REAGENT KIT
K855010 · DFT
Kallestad Laboratories, Inc.
Immunology · 74d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS SUPPORT PACK
K855013 · DEH
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS C4 REAGENT KIT
K855012 · DBI
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS C3 REAGENT KIT
K855011 · CZN
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS IGA REAGENT KIT
K855009 · CZP
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS KAPPA REAGENT KIT
K855008 · DFH
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Feb 26, 1986
QUANTIMETRIC PLUS LAMBDA REAGENT KIT
K855007 · DEH
Kallestad Laboratories, Inc.
Immunology · 72d
Cleared Dec 11, 1985
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT
K854483 · KTO
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Nov 26, 1985
PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS
K853554 · LIQ
Kallestad Laboratories, Inc.
Microbiology · 92d
Cleared Oct 21, 1985
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
K852999 · DEH
Kallestad Laboratories, Inc.
Immunology · 98d
Cleared Sep 19, 1985
ALLERCOAT ALLERGEN DISCS
K852794 · DHB
Kallestad Laboratories, Inc.
Immunology · 80d
Cleared Jul 30, 1985
PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
K852125 · GQL
Kallestad Laboratories, Inc.
Microbiology · 76d
Cleared Jul 10, 1985
QUANTICLONE IGE RADIOIMMUNASSAY
K852268 · DGC
Kallestad Laboratories, Inc.
Immunology · 43d
Cleared Jul 11, 1984
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
K841864 · DEH
Kallestad Laboratories, Inc.
Immunology · 68d
Cleared Jun 07, 1984
ALLERCOAT ALLERGEN DISCS
K842125 · DGC
Kallestad Laboratories, Inc.
Immunology · 9d
Cleared Mar 09, 1984
ALLERCOAT MULTISCREEN DISCS
K840360 · DHB
Kallestad Laboratories, Inc.
Immunology · 43d
Cleared Jun 02, 1983
ALLERCOAT ALLERGEN DISCS
K831326 · DGC
Kallestad Laboratories, Inc.
Immunology · 38d