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
889–912 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 29, 2002
CIC-C1Q EIA
K012576 · DAK
American Laboratory Products Co., Ltd.
Immunology · 173d
Cleared Jan 08, 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956 · MSV
Diamedix Corp.
Immunology · 39d
Cleared Jan 07, 2002
NYCOCARD CRP CONTROL
K014084 · DCK
Primus Corp.
Immunology · 27d
Cleared Jan 02, 2002
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
K013304 · DBY
Becton Dickinson Infusion Therapy...
Immunology · 90d
Cleared Dec 21, 2001
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K013568 · DHX
Bayer Corp.
Immunology · 56d
Cleared Dec 21, 2001
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
K013628 · MSV
Diamedix Corp.
Immunology · 46d
Cleared Dec 14, 2001
GORE INTRODUCER SHEATH
K013282 · DBY
W.L. Gore & Associates, Inc.
Immunology · 73d
Cleared Dec 14, 2001
CONVOY ADVANCED DELIVERY SHEATH KIT
K013866 · DBY
Boston Scientific
Immunology · 23d
Cleared Dec 10, 2001
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
K011244 · LKJ
Zeus Scientific, Inc.
Immunology · 231d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K012359 · DBI
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361 · CZW
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 29, 2001
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM
K013432 · KTL
Immuno Concepts, Inc.
Immunology · 45d
Cleared Nov 20, 2001
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE
K013332 · JJY
Cliniqa Corporation
Immunology · 42d
Cleared Nov 14, 2001
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
K013283 · MOB
Immuno Concepts, Inc.
Immunology · 43d
Cleared Nov 14, 2001
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
K013285 · MOB
Immuno Concepts, Inc.
Immunology · 43d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
K012449 · MID
Diamedix Corp.
Immunology · 86d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
K012450 · MID
Diamedix Corp.
Immunology · 86d
Cleared Oct 22, 2001
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K012777 · JZO
Bayer Corp.
Immunology · 63d
Cleared Oct 19, 2001
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6...
K013135 · DHB
Diagnostic Products Corp.
Immunology · 30d
Cleared Oct 15, 2001
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600...
K013134 · DHB
Diagnostic Products Corp.
Immunology · 26d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · MST
Diamedix Corp.
Immunology · 38d
Cleared Sep 28, 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · MST
Diamedix Corp.
Immunology · 38d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
K013077 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
K013079 · MSV
Corgenix, Inc.
Immunology · 14d