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
385–408 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 11, 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6
K100910 · DHB
Siemens Medical Solutions Diagnostics
Immunology · 405d
Cleared May 04, 2011
AFFYMETRIX GENE PROFILING REAGENTS
K103112 · OVA
Affymetrix, Inc.
Immunology · 195d
Cleared Apr 18, 2011
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7...
K100344 · MOI
Siemens Healthcare Diagnostics
Immunology · 437d
Cleared Apr 12, 2011
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI...
K100321 · LTK
Siemens Healthcare Diagnostics
Immunology · 432d
Cleared Apr 06, 2011
DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7...
K100375 · NIG
Siemens Healthcare Diagnostics, Inc.
Immunology · 418d
Cleared Mar 28, 2011
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
K093987 · DHB
Siemens Healthcare Diagnostics, Inc.
Immunology · 459d
Cleared Mar 23, 2011
QUANTA FLASH H-TTG IGG
K101644 · MVM
Inova Diagnostics, Inc.
Immunology · 286d
Cleared Mar 07, 2011
EU-TTG IGA AND EU-TTG IGG
K102964 · MVM
Grifols USA, Inc.
Immunology · 153d
Cleared Feb 23, 2011
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL...
K100464 · NSF
Wako Chemicals USA, Inc.
Immunology · 370d
Cleared Feb 18, 2011
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
K103701 · JIX
Siemens Healthcare Diagnostics, Inc.
Immunology · 60d
Cleared Feb 11, 2011
ELECSYS ANTI-TPO CALSET
K103171 · JIX
Roche Diagnostics
Immunology · 107d
Cleared Dec 15, 2010
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01
K100999 · DHB
Phadia AB
Immunology · 247d
Cleared Dec 09, 2010
IMMULISA DSDNA ANTIBODY ELISA
K101319 · LRM
Immco Diagnostics, Inc.
Immunology · 212d
Cleared Dec 03, 2010
FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS
K102607 · LLL
Biomedical Diagnostics (Bmd) SA
Immunology · 84d
Cleared Dec 01, 2010
CCPOINT
K093908 · NHX
Euro-Diagnostica AB
Immunology · 344d
Cleared Nov 03, 2010
FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
K100917 · MOB
Biomedical Diagnostics (Bmd) SA
Immunology · 215d
Cleared Nov 01, 2010
ELECSYS CA 125 II CALCHECK 5
K102086 · JJX
Roche Diagnostics
Immunology · 98d
Cleared Oct 27, 2010
ORGENTEC RHEUMATOID FACTOR EIA
K100499 · DHR
Orgentec Diagnostika GmbH
Immunology · 247d
Cleared Oct 13, 2010
QUANTA FLASH H-TTG IGA
K094060 · MVM
Inova Diagnostics, Inc.
Immunology · 286d
Cleared Oct 07, 2010
IMMULISA MPO ANTIBODY ELISA
K092599 · MOB
Immco Diagnostics, Inc.
Immunology · 409d
Cleared Oct 07, 2010
IMMULISA PR3 ANTIBODY ELISA
K092600 · MOB
Immco Diagnostics, Inc.
Immunology · 409d
Cleared Oct 07, 2010
IMMULISA ANCA SCREEN ELISA
K092601 · MOB
Immco Diagnostics, Inc.
Immunology · 409d
Cleared Oct 07, 2010
ELECSYS IGE CALCHECK 5
K102269 · JJX
Roche Diagnostics
Immunology · 59d
Cleared Oct 05, 2010
ELECSYS CA 19-9 CALCHECK 5
K101365 · JJX
Roche Diagnostics Corp.
Immunology · 141d