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
3193–3216 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 05, 1982
GAMMA CLQ
K823009 · DAK
Gamma Medical Products, Inc.
Immunology · 24d
Cleared Nov 05, 1982
FLOUROSET IMMUNOFLUORESCENT ANTIBODY
K823055 · DHN
Immulok, Inc.
Immunology · 18d
Cleared Oct 22, 1982
RAST ALLERCOAT ALLERGEN DISCS
K822613 · DGC
Kallestad Laboratories, Inc.
Immunology · 53d
Cleared Oct 22, 1982
ANAZYME ANA PEROXIDASE TEST SYSTEM
K822911 · DAA
Clinical Sciences, Inc.
Immunology · 21d
Cleared Oct 18, 1982
LATEST RF KIT FOR RHEUMATOID FACTOR
K822905 · DHR
Fisher Scientific Co., LLC
Immunology · 19d
Cleared Oct 08, 1982
HISTIMUNE ENZYME-ANA TEST
K822346 · LJM
Icl Scientific
Immunology · 63d
Cleared Sep 21, 1982
ANA HEP-2 FLUORO-KIT
K822397 · DHN
Clinical Sciences, Inc.
Immunology · 42d
Cleared Sep 17, 1982
ANTINUCLEAR ANTOBODY CELL SUBSTRATE
K822607 · DHN
Immulok, Inc.
Immunology · 21d
Cleared Sep 07, 1982
VIVONEX MASS GASTRASTOMY TUBE
K822516 · KHT
Norwich Eaton Pharmaceuticals, Inc.
Immunology · 18d
Cleared Aug 27, 1982
RHEUMATOID FACTOR REFERENCE PREPARA.
K821941 · DHR
Armkel, LLC
Immunology · 59d
Cleared Aug 27, 1982
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
K821949 · DAK
Ortho Diagnostic Systems, Inc.
Immunology · 58d
Cleared Aug 03, 1982
PHADEBAS RAST TEST
K822141 · DHB
Pharmacia, Inc.
Immunology · 14d
Cleared Jul 30, 1982
MEASELISA TEST KIT
K821762 · LJB
M.A. Bioproducts
Immunology · 45d
Cleared Jul 22, 1982
RIA-QUANT FPA TEST KIT
K821151 · DAN
Mallinckrodt Critical Care
Immunology · 87d
Cleared Jul 22, 1982
QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.
K821984 · DCK
Kallestad Laboratories, Inc.
Immunology · 16d
Cleared Jul 16, 1982
ORTHO CLASSICAL PATHWAY COMPL. TEST
K821898 · DBA
Ortho Diagnostic Systems, Inc.
Immunology · 18d
Cleared Jul 13, 1982
RIAGEN B-HCG RIA
K821657 · JHI
Biogenex Laboratories
Immunology · 39d
Cleared Jul 02, 1982
SERO/TEX MONO TEST
K821386 · KTN
Texas Immunology, Inc.
Immunology · 53d
Cleared Jul 02, 1982
SERO/TEX CRP TEST
K821388 · DCN
Texas Immunology, Inc.
Immunology · 53d
Cleared Jun 25, 1982
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
K821806 · DAK
Ortho Diagnostic Systems, Inc.
Immunology · 8d
Cleared Jun 25, 1982
ADVANCE C-REACTIVE PROTEIN (CRP) ASSAY
K821815
Syva Co.
Immunology · 7d
Cleared Jun 23, 1982
VAST VENTREX ALLERGY SYSTEMS TESTS
K821451 · DHB
Ventrex Laboratories, Inc.
Immunology · 40d
Cleared Jun 22, 1982
CEFOPERAZONE 75MCG SENSIT- DISCS
K821262 · JTN
Difco Laboratories, Inc.
Immunology · 50d
Cleared Jun 10, 1982
ANTINUCLEAR ANTIBODY SCREEN FLOURESC
K821576 · DBL
Immuno-Products Industries
Immunology · 13d