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
385–408 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 27, 2011
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE,...
K101251 · DHB
Phadia AB
Immunology · 388d
Cleared May 26, 2011
CYFRA 21-1 EIA MODEL 211-10
K100831 · OVK
Fujirebio Diagnostics,Inc.
Immunology · 428d
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