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
337–360 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 13, 2013
TRANSFERRIN KIT FOR USE ON THE SPAPLUS
K120236 · DDG
The Binding Site Group , Ltd.
Immunology · 384d
Cleared Jan 29, 2013
IMMUNOCAP ALLERGEN K82
K121463 · DHB
Thermo Fisher Scientific
Immunology · 257d
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