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
553–576 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 30, 2007
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
K070552 · JIT
Dade Behring, Inc.
Immunology · 62d
Cleared Apr 23, 2007
TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL#...
K063766 · DDG
Good Biotech Corp.
Immunology · 124d
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