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
457–480 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 28, 2009
EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
K083052 · MST
Euroimmun Us, Inc.
Immunology · 287d
Cleared Jun 22, 2009
VIDAS CA 15-3 ASSAY
K080469 · LTK
bioMerieux, Inc.
Immunology · 487d
Cleared Jun 22, 2009
LAMBDA LIGHT CHAINS
K083601 · DEH
SENTINEL CH. SpA
Immunology · 199d
Cleared May 28, 2009
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY,...
K083117 · LKO
Phadia US, Inc.
Immunology · 218d
Cleared May 26, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K090257 · DHB
Siemens Healthcare Diagnostics
Immunology · 113d
Cleared May 21, 2009
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K083391 · JZO
Diagnostic Hybrids, Inc.
Immunology · 185d
Cleared May 20, 2009
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS
K083850 · MOB
Euroimmun Us, Inc.
Immunology · 147d
Cleared May 06, 2009
HUMAN BETA-2 MICROGLOBULIN KIT
K083289 · JZG
The Binding Site, Ltd.
Immunology · 180d
Cleared Apr 29, 2009
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION...
K090594 · CFN
Siemens Healthcare Diagnostics
Immunology · 55d
Cleared Apr 27, 2009
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
K090236 · LOJ
Siemens Healthcare Diagnostics
Immunology · 84d
Cleared Apr 17, 2009
CAPILLARYS IMMUNOTYPING, MODEL 2100
K082085 · CFF
Sebia
Immunology · 268d
Cleared Apr 15, 2009
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
K083381 · LRM
Euroimmun Us, Inc.
Immunology · 152d
Cleared Apr 14, 2009
MINICAP IMMUNOTYPING, MODEL: 2300
K082388 · CFF
Sebia
Immunology · 238d
Cleared Apr 10, 2009
VIDAS CA 125 II ASSAY
K080561 · LTK
bioMerieux, Inc.
Immunology · 407d
Cleared Apr 10, 2009
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO...
K082759 · LKJ
Phadia US, Inc.
Immunology · 200d
Cleared Apr 07, 2009
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
K082130 · MOB
Euroimmun Us, Inc.
Immunology · 252d
Cleared Mar 24, 2009
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN...
K083445 · CFN
Siemens Healthcare Diagnostics
Immunology · 123d
Cleared Mar 24, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083853 · DHB
Siemens Healthcare Diagnostics
Immunology · 90d
Cleared Mar 18, 2009
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
K081615 · DHX
Olympus America, Inc.
Immunology · 282d
Cleared Mar 18, 2009
C-REACTIVE PROTEIN (LATEX)
K083444 · DCN
Roche Diagnostics Corp.
Immunology · 117d
Cleared Mar 16, 2009
OLYMPUS AFP - ALPHA-FETOPROTEIN
K081709 · LOJ
Olympus Life Science Research Europa...
Immunology · 272d
Cleared Mar 16, 2009
IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID...
K081830 · DHB
Phadia AB
Immunology · 259d
Cleared Mar 16, 2009
EUROIMMUN ANTI BP 180-4X ELISA (IGG)
K083615 · OEG
Euroimmun Us, Inc.
Immunology · 98d
Cleared Mar 13, 2009
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
K083188 · LJM
Phadia US, Inc.
Immunology · 135d