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
1225–1248 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC...
K990026 · JJX
Ortho-Clinical Diagnostics, Inc.
Immunology · 24d
Cleared Jan 28, 1999
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
K982634 · KTN
Oxoid , Ltd.
Immunology · 184d
Cleared Jan 28, 1999
AUTOSTAT II ANA SCREEN ELISA
K983655 · LJM
Cogent Diagnotics , Ltd.
Immunology · 101d
Cleared Jan 28, 1999
IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5
K984132 · DCK
Diagnostic Products Corp.
Immunology · 71d
Cleared Jan 28, 1999
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA
K984137 · MVM
Inova Diagnostics, Inc.
Immunology · 71d
Cleared Jan 26, 1999
APOB
K983281 · DFC
Abbott Laboratories
Immunology · 130d
Cleared Jan 26, 1999
NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY
K983992 · JZO
Nichols Institute Diagnostics
Immunology · 78d
Cleared Jan 25, 1999
RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
K984045 · DHR
Kamiya Biomedical Co.
Immunology · 73d
Cleared Jan 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE...
K984321 · CDD
Ortho-Clinical Diagnostics, Inc.
Immunology · 50d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME...
K984516 · MOB
Zeus Scientific, Inc.
Immunology · 24d
Cleared Dec 28, 1998
AUTOSTAT II ENA SCREEN ELISA
K983921 · LLL
Cogent Diagnotics , Ltd.
Immunology · 54d
Cleared Dec 23, 1998
OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
K984145 · DDR
Olympus Diagnostica GmbH
Immunology · 34d
Cleared Dec 22, 1998
REAADS IGA ANTI-B2GP 1 TEST KIT
K982434 · MSV
Corgenix, Inc.
Immunology · 161d
Cleared Dec 22, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
K984173 · MID
Zeus Scientific, Inc.
Immunology · 32d
Cleared Dec 22, 1998
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
K984462 · LLL
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
K984464 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
K984470 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
K984473 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
K984475 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
K984476 · LKO
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
K984478 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K984479 · LKP
Bio-Rad
Immunology · 6d
Cleared Dec 18, 1998
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
K983031 · LOJ
Ortho-Clinical Diagnostics, Inc.
Immunology · 109d
Cleared Dec 18, 1998
TRANSFERRIN SPQ III ANTIBODY REAGENT SET
K983880 · DDG
DiaSorin, Inc.
Immunology · 46d