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
2881–2904 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 25, 1985
PHARMACIA IGE RIA MODIFIED
K851156 · DGC
Pharmacia, Inc.
Immunology · 34d
Cleared Apr 19, 1985
FISHER DIAGNOSTICS LATEST-CRP TEST KIT
K850160 · DCK
Fisher Diagnostics
Immunology · 94d
Cleared Apr 12, 1985
MAST ALLERGY SYSTEM
K843694 · DHB
Mast Immunosystems
Immunology · 205d
Cleared Apr 12, 1985
MAST LUMINESCENT ALLERGY SYSTEM
K844629 · DHB
Mast Immunosystems
Immunology · 136d
Cleared Apr 12, 1985
LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS
K850296 · DHR
Behring Diagnostics, Inc.
Immunology · 78d
Cleared Apr 12, 1985
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO
K850574 · JJY
American Dade
Immunology · 58d
Cleared Apr 12, 1985
TOTAL HIGE ENZYME IMMUNOASSAY
K850786 · DGC
Nms Pharmaceuticals, Inc.
Immunology · 45d
Cleared Mar 19, 1985
ACCULEVEL THEOPHYLLINE TEST
K844642 · KLS
Syva Co.
Immunology · 111d
Cleared Mar 14, 1985
AUTOFLUOR V SYSTEM
K842991 · DHN
Tech America Diagnostics
Immunology · 227d
Cleared Mar 14, 1985
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M
K850586 · DAO
Applications Lab
Immunology · 29d
Cleared Mar 14, 1985
SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN
K850587 · DEM
Applications Lab
Immunology · 29d
Cleared Mar 12, 1985
TSS/FIK
K842501
Zarcon Corp.
Immunology · 259d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR HAPTOGLOBIN
K850584 · DAD
Applications Lab
Immunology · 20d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR COMPLEMENT C3
K850588 · CZW
Applications Lab
Immunology · 20d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR TRANSFERRIN
K850589 · DDG
Applications Lab
Immunology · 20d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN
K850603 · DEB
Applications Lab
Immunology · 18d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A
K850582 · CZP
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G
K850583 · DEW
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR COMPLEMENT C4
K850585 · DBI
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
K850590 · DCK
Applications Lab
Immunology · 16d
Cleared Feb 26, 1985
PHYSIO GAS ANALYZER
K843423 · LLL
Research Medical, Inc.
Immunology · 179d
Cleared Feb 04, 1985
CORDIA IC
K844294 · DAK
Cordis Corp.
Immunology · 90d
Cleared Feb 04, 1985
SERATEST ENA(RNP/SM) DETERMINATION
K844743 · LLL
Seragen Diagnostics, Inc.
Immunology · 61d
Cleared Jan 08, 1985
RESPIRALEX LATEX AGGLUTINATION TEST
K844399 · GTZ
Orion Diagnostica, Inc.
Immunology · 56d