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
889–912 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 19, 2002
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
K014293 · DBF
Kamiya Biomedical Co.
Immunology · 53d
Cleared Feb 08, 2002
UROVYSION BLADDER CANCER RECURRENCE KIT
K013785 · MMW
Vysis
Immunology · 86d
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