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
457–480 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Mar 13, 2009
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR,...
K083463 · JZG
Siemens Healthcare Diagnostics
Immunology · 109d
Cleared Mar 11, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083314 · DHB
Siemens Healthcare Diagnostics
Immunology · 121d