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
433–456 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 05, 2010
THERATEST EL-ANTI-CCP/2
K090753 · NHX
Theratest Laboratories, Inc.
Immunology · 350d
Cleared Mar 01, 2010
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
K082823 · CFN
The Binding Site Group , Ltd.
Immunology · 522d
Cleared Feb 23, 2010
AESKULISA MPO, MODEL 30-7303US
K091860 · MOB
Aesku Diagnostics
Immunology · 249d
Cleared Feb 04, 2010
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA
K091522 · MST
Immco Diagnostics, Inc.
Immunology · 258d
Cleared Feb 01, 2010
QUANTA LITE APS/PT IGG AND IGM ELISA
K090755 · OPN
Inova Diagnostics, Inc.
Immunology · 318d
Cleared Jan 19, 2010
IMMUNOCAP RAPID READER, MODEL 12-3600-10
K092978 · DHB
Phadia US, Inc.
Immunology · 113d
Cleared Jan 15, 2010
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
K091052 · DCN
Abaxis, Inc.
Immunology · 277d
Cleared Dec 30, 2009
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND...
K090920 · CFN
The Binding Site, Ltd.
Immunology · 273d
Cleared Dec 28, 2009
HUMAN IGD KIT FOR USE ON SPAPLUS
K092450 · CZJ
The Binding Site
Immunology · 140d
Cleared Dec 11, 2009
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · DBF
Beckman Coulter, Inc.
Immunology · 119d
Cleared Dec 03, 2009
MAS AND MINI-TROL PTH CONTROL
K092749 · JJX
Microgenics Corporation
Immunology · 86d
Cleared Nov 20, 2009
IVD TECHNOLOGIES ACHRAB TEST KIT
K091468 · NST
Ivd Technologies
Immunology · 186d
Cleared Nov 20, 2009
IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01
K092050 · DHB
Phadia AB
Immunology · 136d
Cleared Nov 19, 2009
IMMUNOSCAN CCPLUS
K091657 · NHX
Euro-Diagnostica AB
Immunology · 163d
Cleared Oct 29, 2009
IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM
K083080 · DHR
Sqi Diagnostics Systems
Immunology · 378d
Cleared Oct 28, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
K091984 · DHB
Siemens Medical Solutions Diagnostics
Immunology · 118d
Cleared Oct 21, 2009
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE,...
K092283 · DFZ
Siemens Healthcare Diagnostics
Immunology · 84d
Cleared Oct 09, 2009
THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
K092757 · MSV
Thera-Test Laboratories, Inc.
Immunology · 30d
Cleared Sep 25, 2009
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25,...
K083868 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 270d
Not Cleared Sep 11, 2009
OVA1 TEST
DEN090004 · ONX
Vermillion
Immunology · 51d
Cleared Sep 03, 2009
KAPPA LIGHT CHAINS
K083602 · DFH
SENTINEL CH. SpA
Immunology · 272d
Cleared Sep 03, 2009
THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119,...
K090760 · JZO
Theratest Laboratories, Inc.
Immunology · 164d
Cleared Aug 07, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
K083053 · MST
Euroimmun Us, Inc.
Immunology · 297d
Cleared Aug 06, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K091289 · DHB
Siemens Healthcare Diagnostics
Immunology · 97d