FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×
3,792 results
625–648 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Jun 28, 2005
VARELISA RECOMBI CTD SCREEN, MODEL 13096
K050967 · LJM
Sweden Diagnostics (Germany) GmbH
Immunology · 71d
Cleared Jun 27, 2005
CAPILLARY'S IMMUNOTYPING (PN 2100)
K042939 · DFH
Sebia, Inc.
Immunology · 245d