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
553–576 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 11, 2007
QUANTA LITE RNA POL III ELISA
K070066 · NYO
Inova Diagnostics, Inc.
Immunology · 93d
Cleared Apr 04, 2007
QUANTA LITE SS-A 52 ELISA
K063565 · OBE
Inova Diagnostics, Inc.
Immunology · 127d
Cleared Apr 02, 2007
FASTPACK TOTAL PSA METHOD VERIFICATION KIT
K062957 · JJX
Qualigen, Inc.
Immunology · 185d
Cleared Mar 20, 2007
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20,...
K063347 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 134d
Cleared Mar 19, 2007
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
K063150 · CZW
Thermo Electron OY
Immunology · 154d
Cleared Mar 14, 2007
ELIA GLIADIN IGA, IGG AND CELIAC CONTROL
K063775 · MST
Phadia US, Inc.
Immunology · 83d
Cleared Mar 12, 2007
QUANTA LITE H-TTG/DGP SCREEN
K070083 · MST
Inova Diagnostics, Inc.
Immunology · 62d
Cleared Feb 15, 2007
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1...
K063425 · DGC
Dade Behring, Inc.
Immunology · 94d
Cleared Feb 15, 2007
DIMENSION VISTA
K063655 · CHN
Dade Behring, Inc.
Immunology · 69d
Cleared Jan 31, 2007
CERULOPLASMIN, MODEL 2055953
K062114 · CHN
Roche Diagnostics Corp.
Immunology · 191d
Cleared Jan 31, 2007
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301
K062368 · OAU
Wako Chemicals USA, Inc.
Immunology · 170d
Cleared Jan 26, 2007
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL...
K063272 · JZG
Dade Behring, Inc.
Immunology · 88d
Cleared Jan 24, 2007
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1...
K063322 · DDG
Dade Behring, Inc.
Immunology · 82d
Cleared Jan 11, 2007
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND...
K063610 · DEM
Dade Behring, Inc.
Immunology · 38d
Cleared Dec 29, 2006
ELIA CELIKEY IGA WELL, MODEL 14-5517-01
K062787 · MVM
Phadia US, Inc.
Immunology · 102d
Cleared Dec 26, 2006
ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01
K062583 · MVM
Phadia US, Inc.
Immunology · 116d
Cleared Dec 22, 2006
QUANTA LITE INTRINSIC FACTOR ELISA
K061841 · LIG
Inova Diagnostics, Inc.
Immunology · 176d
Cleared Dec 13, 2006
AESKULSKA BETA2-GLYCO-A
K062217 · MSV
Aesku, Inc.
Immunology · 134d
Cleared Dec 13, 2006
QUANTA LITE CELIAC DGP SCREEN
K062708 · MST
Inova Diagnostics, Inc.
Immunology · 93d
Cleared Dec 04, 2006
EDIA ANTI-CCP
K062045 · NHX
Euro-Diagnostica AB
Immunology · 138d
Cleared Nov 21, 2006
FIDIS TM THYRO, MODEL MX002
K061794 · JZO
Biomedical Diagnostics (Bmd) SA
Immunology · 148d
Cleared Nov 21, 2006
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
K062183 · LRM
The Binding Site, Ltd.
Immunology · 113d
Cleared Nov 20, 2006
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
K062746 · DBF
Medicon Hellas S.A
Immunology · 67d
Cleared Oct 18, 2006
QUANTA LITE PBC SCREEN IGG/IGA ELISA
K061842 · NRI
Inova Diagnostics, Inc.
Immunology · 111d