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
481–504 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 13, 2009
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR,...
K083463 · JZG
Siemens Healthcare Diagnostics
Immunology · 109d
Cleared Mar 11, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083314 · DHB
Siemens Healthcare Diagnostics
Immunology · 121d
Cleared Feb 10, 2009
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
K082129 · CFN
The Binding Site, Ltd.
Immunology · 196d
Cleared Dec 19, 2008
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
K081827 · CFN
The Binding Site, Ltd.
Immunology · 175d
Cleared Dec 19, 2008
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS,...
K082503 · DFH
Siemens Healthcare Diagnostics
Immunology · 112d
Cleared Oct 30, 2008
AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
K082717 · JJY
Aalto Scientific, Ltd.
Immunology · 43d
Cleared Oct 27, 2008
QUANTA LITE OMP PLUS ELISA
K081248 · OKM
Inova Diagnostics, Inc.
Immunology · 178d
Cleared Oct 15, 2008
BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT
K081674 · MST
The Binding Site, Ltd.
Immunology · 120d
Cleared Oct 09, 2008
VIDAS CEA (S) ASSAY
K080194 · DHX
bioMerieux, Inc.
Immunology · 258d
Cleared Sep 26, 2008
VIDAS AFP ASSAY
K080017 · LOJ
bioMerieux, Inc.
Immunology · 267d
Cleared Sep 11, 2008
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
K081338 · NHX
Roche Diagnostics
Immunology · 121d
Cleared Sep 08, 2008
LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
K082036 · JJY
Bio-Rad Laboratories
Immunology · 53d
Cleared Aug 25, 2008
MESACUP MODELS BP180 AND BP230 ELISA KITS
K071961 · OEG
Mbl International Corporation
Immunology · 406d
Cleared Aug 11, 2008
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493,...
K080634 · DDG
Beckman Coulter, Inc.
Immunology · 158d
Cleared Aug 08, 2008
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM...
K081299 · DDG
Siemens Healthcare Diagnostics, Inc.
Immunology · 92d
Cleared Jul 28, 2008
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · JZO
Roche Diagnostics Corp.
Immunology · 196d
Cleared Jul 28, 2008
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM...
K081161 · CFN
Dade Behring, Inc.
Immunology · 95d
Cleared Jul 21, 2008
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM...
K081249 · DEB
Dade Behring, Inc.
Immunology · 80d
Cleared Jul 01, 2008
AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101
K072901 · NTY
Amdl, Inc.
Immunology · 264d
Cleared Jul 01, 2008
CAPILLARYS URINE
K080916 · JKM
Sebia
Immunology · 90d
Cleared Jun 25, 2008
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
K071603 · DHX
Dade Behring, Inc.
Immunology · 379d
Cleared Jun 17, 2008
KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT
K080523 · NST
Kronus Market Development Associates,...
Immunology · 112d
Cleared Jun 09, 2008
HE4 EIA, MODEL: 404-10 US
K072939 · OIU
Fujirebio Diagnostics,Inc.
Immunology · 236d
Cleared Jun 04, 2008
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION...
K071597 · LOJ
Dade Behring, Inc.
Immunology · 358d