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
505–528 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 22, 2008
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
K080159 · JZO
Kronus Market Development Associates,...
Immunology · 120d
Cleared May 22, 2008
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
K081217 · DHB
Hycor Biomedical, Inc.
Immunology · 22d
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