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
481–504 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared May 22, 2008
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT
K080159 · JZO
Kronus Market Development Associates,...
Immunology · 120d
Cleared May 22, 2008
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
K081217 · DHB
Hycor Biomedical, Inc.
Immunology · 22d