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
337–360 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 09, 2013
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE,...
K121399 · NSU
Luminex Corp.
Immunology · 245d
Cleared Dec 20, 2012
AP 72OS SEMI-AUTOMATED INSTRUMENT
K112910 · DHB
Hitachi Chemical Diagnostics, Inc.
Immunology · 444d
Cleared Dec 20, 2012
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT
K121046 · PCG
Kronus Market Development Associates,...
Immunology · 258d
Cleared Dec 14, 2012
GLIADIN IGA AND GLIADIN LGA
K113377 · MST
Grifols USA, LLC
Immunology · 394d
Cleared Dec 05, 2012
ELECSYS CA 15-3 II CALCHECK 5
K122242 · JJX
Roche Diagnostics
Immunology · 131d
Cleared Oct 25, 2012
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY...
K113020 · MID
Immco Diagnostics, Inc.
Immunology · 380d
Cleared Oct 15, 2012
AESKUSLIDES ANA HEP-2
K120889 · DHN
Aesku Diagnostics
Immunology · 206d
Cleared Sep 20, 2012
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS,...
K113863 · MST
Inova Diagnostics, Inc.
Immunology · 265d
Cleared Sep 13, 2012
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
K113841 · DHB
Phadia US, Inc.
Immunology · 260d
Cleared Sep 11, 2012
EUROIMMUN ANTI-SLA/LP ELISA(LGG)
K112221 · NIY
Euroimmun US
Immunology · 406d
Cleared Sep 11, 2012
EUROIMMUN ANTI-LKM-1 ELISA(LGG)
K112223 · NBS
Euroimmun US
Immunology · 406d
Cleared Sep 10, 2012
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4...
K112624 · OIU
Roche Diagnostics
Immunology · 368d
Cleared Aug 30, 2012
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
K122066 · JZG
The Binding Site Group , Ltd.
Immunology · 45d
Cleared Aug 24, 2012
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT
K120169 · CFF
Grifols USA, LLC
Immunology · 218d
Cleared Aug 17, 2012
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
K113809 · DCN
Hitachi Chemical Diagnostics, Inc.
Immunology · 238d
Cleared Jul 31, 2012
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
K112545 · MOB
Inova Diagnostics, Inc.
Immunology · 334d
Cleared Jul 11, 2012
HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR...
K113349 · DAE
The Binding Site Group , Ltd.
Immunology · 240d
Cleared Jul 09, 2012
ANA-SCREEN WITH MDSS
K113610 · LKJ
Bio-Rad Laboratories
Immunology · 216d
Cleared Jun 26, 2012
THE HELENA V8 IMMUNODISPLACEMENT KIT
K111369 · CFF
Helena Laboratories Uk, Ltd.
Immunology · 407d
Cleared Jun 22, 2012
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
K112414 · MSV
Phadia US, Inc.
Immunology · 305d
Cleared May 30, 2012
KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
K111956 · PAF
Kronus Market Development Associates,...
Immunology · 324d
Cleared May 24, 2012
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
K121232 · DBF
Kamiya Biomedical Company
Immunology · 30d
Cleared Mar 30, 2012
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
K103834 · MID
Bio-Rad Laboratories
Immunology · 456d
Cleared Feb 27, 2012
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
K103824 · CFN
The Binding Site
Immunology · 424d