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
2593–2616 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 07, 1987
CIBA CORNING MAGIC LITE FERRITIN
K873573 · DBF
Ciba Corning Diagnostics Corp.
Immunology · 35d
Cleared Oct 07, 1987
IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT
K873676 · DHB
Incstar Corp.
Immunology · 23d
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