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
505–528 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 13, 2008
MODIFICATION TO AESKULISA DS DNA G
K081251 · LSW
Aesku Diagnostics
Immunology · 11d
Cleared May 02, 2008
AESKULISA ANA HEP-2, REF 30-7115US
K081104 · LKJ
Aesku Diagnostics
Immunology · 14d
Cleared Apr 10, 2008
KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT
K073590 · OIF
Kronus Market Development Associates,...
Immunology · 112d
Cleared Apr 04, 2008
IGG ANTI-ATHEROX TEST KIT
K072032 · MSV
Corgenix, Inc.
Immunology · 255d
Cleared Apr 01, 2008
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
K072658 · DCN
Siemens Medical Solutions Diagnostics
Immunology · 194d
Cleared Mar 06, 2008
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277 · DCN
Roche Diagnostics Corp.
Immunology · 106d
Cleared Mar 05, 2008
QUANTA LITE CCP3.1 IGG/IGA ELISA
K072944 · NHX
Inova Diagnostics, Inc.
Immunology · 140d
Cleared Mar 05, 2008
HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
K080322 · DHB
Hycor Biomedical, Inc.
Immunology · 28d
Cleared Feb 26, 2008
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION...
K073561 · CFN
Dade Behring, Inc.
Immunology · 69d
Cleared Feb 12, 2008
QUANTA LITE H-TTG SCREEN
K073145 · MVM
Inova Diagnostics, Inc.
Immunology · 96d
Cleared Feb 11, 2008
QUANTA PLEX CELIAC IGG PROFILE
K072632 · MVM
Inova Diagnostics, Inc.
Immunology · 146d
Cleared Feb 11, 2008
OLYMPUS IGM REAGENT
K073487 · CFN
Olympus America, Inc.
Immunology · 61d
Cleared Feb 11, 2008
OLYMPUS IGA REAGENT
K073489 · CFN
Olympus America, Inc.
Immunology · 61d
Cleared Feb 11, 2008
OLYMPUS IGG REAGENT
K073490 · CFN
Olympus America, Inc.
Immunology · 61d
Cleared Feb 01, 2008
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
K072889 · CFN
The Binding Site, Ltd.
Immunology · 114d
Cleared Jan 28, 2008
QUANTA LITE F-ACTIN IGA ELISA
K072967 · MVM
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Jan 15, 2008
ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01
K072149 · LLL
Phadia US, Inc.
Immunology · 165d
Cleared Dec 31, 2007
EUROIMMUN ANTI-CCP ELISA
K070789 · NHX
Euroimmun Us, LLC
Immunology · 284d
Cleared Dec 21, 2007
MODIFICATION TO FIDIS VASCULITIS, MODEL MX007
K070458 · MOB
Biomedical Diagnostics (Bmd) SA
Immunology · 308d
Cleared Dec 21, 2007
CAPILLARYS URINE (PN 2012)
K070486 · JKM
Sebia, Inc.
Immunology · 304d
Cleared Dec 21, 2007
DIMENSION VISTA C1 IN
K072965 · DBA
Dade Behring, Inc.
Immunology · 60d
Cleared Dec 19, 2007
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
K071210 · LKO
Biomedical Diagnostics (Bmd) SA
Immunology · 232d
Cleared Dec 19, 2007
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
K072078 · JZG
Biokit, S.A.
Immunology · 142d
Cleared Dec 07, 2007
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393 · LSW
Phadia US, Inc.
Immunology · 102d