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
2593–2616 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 07, 1987
QM300 TRANSFERRIN ANTIBODY PACK
K873789 · DDG
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Sep 23, 1987
MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
K872794 · MSJ
Medix Biotech, Inc.
Immunology · 71d
Cleared Sep 23, 1987
RRT SHORT RAGWEED TEST KIT
K873406 · DHB
Incstar Corp.
Immunology · 29d
Cleared Sep 23, 1987
RRT SYSTEM LASER REFLECTOMETER ANALYZER
K873407 · JZW
Incstar Corp.
Immunology · 29d
Cleared Sep 22, 1987
ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS
K873249 · LKJ
Cytotech, Inc.
Immunology · 36d
Cleared Sep 21, 1987
TRI-LEVEL LIGAND CONTROL
K873450 · JJX
Ciba Corning Diagnostics Corp.
Immunology · 25d
Cleared Sep 14, 1987
HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE
K873033 · JHI
Serono Diagnostics, Inc.
Immunology · 41d
Cleared Sep 10, 1987
ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5
K872801 · DGO
Diagnostic Products Corp.
Immunology · 57d
Cleared Sep 10, 1987
ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5
K872913 · DGC
Diagnostic Products Corp.
Immunology · 48d
Cleared Sep 01, 1987
THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS
K872085 · LSW
Immunodiagnostics, Ltd.
Immunology · 92d
Cleared Aug 28, 1987
ULTRASCAN IGE ASSAY KIT
K872968 · DGC
Specialty Medical Industries, Inc.
Immunology · 30d
Cleared Aug 17, 1987
BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
K872845 · DHN
Bion Ent., Ltd.
Immunology · 28d
Cleared Aug 12, 1987
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
K871994 · LLL
Behring Diagnostics, Inc.
Immunology · 78d
Cleared Aug 12, 1987
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K872800 · DEW
Abbott Laboratories
Immunology · 28d
Cleared Aug 12, 1987
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
K872834 · CZJ
Helena Laboratories
Immunology · 26d
Cleared Aug 12, 1987
IMMUNO/SLE
K872910 · DHC
Immunostics Co., Inc.
Immunology · 19d
Cleared Jul 23, 1987
CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY
K872426 · DBA
Cytotech, Inc.
Immunology · 31d
Cleared Jul 23, 1987
QM300 C4 ANTIBODY PACK
K872599 · DBI
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 21d
Cleared Jul 21, 1987
STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
K871972 · DGE
American Dade
Immunology · 61d
Cleared Jul 21, 1987
ANTI-DNP MICROASSAY
K872560 · DHN
Diamedix Corp.
Immunology · 22d
Cleared Jul 21, 1987
QM300 HAPTOGLOBIN ANTIBODY PACK
K872717 · DAD
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 11d
Cleared Jul 16, 1987
ALTERNARIA TENUIS ALLERGEN DISC
K871684 · DHB
Incstar Corp.
Immunology · 78d
Cleared Jul 13, 1987
SWEET VERNAL ALLERGEN DISC
K871723 · DHB
Incstar Corp.
Immunology · 70d
Cleared Jul 09, 1987
KALLESTAD QM300 IGM ANTIBODY PACK
K872237 · DFT
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 29d