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

Filters: Immunology ×
3,794 results
625–648 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 12, 2005
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
K052133 · NHX
Eurodiagnostica
Immunology · 129d
Cleared Nov 23, 2005
IGD DIAGNOSTIC TEST KITS
K051299 · CZJ
The Binding Site, Ltd.
Immunology · 189d
Cleared Nov 23, 2005
WIESLAB CAP MPO-ANCA
K051455 · MOB
Eurodiagnostica
Immunology · 174d
Cleared Nov 23, 2005
QUANTA LITE CCP3 IGG ELISA
K052264 · NHX
Inova Diagnostics, Inc.
Immunology · 96d
Cleared Nov 22, 2005
WIESLAB CAP PR-3 ANCA
K051458 · MOB
Eurodiagnostica
Immunology · 173d
Cleared Nov 18, 2005
ACETYLCHOLINE RECEPTOR AB (ARAB)RRA
K051144 · NST
Ibl-Hamburg GmbH
Immunology · 198d
Cleared Nov 14, 2005
AESKULISA ASCA A
K051492 · NBT
Aesku, Inc.
Immunology · 161d
Cleared Nov 04, 2005
KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
K051061 · NWG
Kronus Market Development Associates,...
Immunology · 192d
Cleared Oct 27, 2005
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH...
K043341 · NVI
Bio-Rad Laboratories, Inc.
Immunology · 328d
Cleared Oct 27, 2005
QUANTA LITE M2 EP (MIT3) ELISA
K052262 · DBM
Inova Diagnostics, Inc.
Immunology · 69d
Cleared Oct 25, 2005
ARCHITECT CA 19-9XR ASSAY
K052000 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 92d
Cleared Oct 21, 2005
SENTINEL CERULOPLASMIN
K051456 · JFR
Sentinel Ch. Srl
Immunology · 141d
Cleared Oct 07, 2005
THERATEST EL-ANA PROFILES
K051066 · LKP
Theratest Laboratories, Inc.
Immunology · 164d
Cleared Oct 04, 2005
QUANTA LITE GLIADIN IGG II
K052142 · MST
Inova Diagnostics, Inc.
Immunology · 57d
Cleared Oct 04, 2005
QUANTA LITE GLIADIN IGA II
K052143 · MST
Inova Diagnostics, Inc.
Immunology · 57d
Cleared Oct 03, 2005
FIDIS CONNECTIVE 8
K050286 · LLL
Biomedical Diagnostics (Bmd) SA
Immunology · 238d
Cleared Sep 06, 2005
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650...
K051915 · DFH
The Binding Site, Ltd.
Immunology · 53d
Cleared Aug 19, 2005
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
K052082 · JMG
Beckman Coulter, Inc.
Immunology · 17d
Cleared Aug 16, 2005
QUANTIA IGE
K050493 · DGC
Biokit, S.A.
Immunology · 169d
Cleared Aug 16, 2005
QUANTIA BETA-2 MICROGLOBULIN
K050613 · JZG
Biokit, S.A.
Immunology · 159d
Cleared Aug 04, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K051890 · JZO
Roche Diagnostics Corp.
Immunology · 23d
Cleared Jul 28, 2005
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
K042579 · NBT
The Binding Site
Immunology · 309d
Cleared Jul 06, 2005
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET
K050231 · JIT
Roche Diagnostics Corp.
Immunology · 161d
Cleared Jul 06, 2005
ELECSYS CA 19-9 CALCHECK
K051185 · JJY
Roche Diagnostics Corp.
Immunology · 58d