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
433–456 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Jul 28, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
K083052 · MST
Euroimmun Us, Inc.
Immunology · 287d
Cleared Jun 22, 2009
VIDAS CA 15-3 ASSAY
K080469 · LTK
bioMerieux, Inc.
Immunology · 487d