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
769–792 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 24, 2003
QUANTA PLEX ENA PROFILE 5
K030681 · LLL
Inova Diagnostics, Inc.
Immunology · 50d
Cleared Apr 21, 2003
IBD-QUIK CHEK
K030704 · DEG
Techlab, Inc.
Immunology · 46d
Cleared Apr 11, 2003
RDI EXTENDED RANGE CRP CALIBRATOR SET
K030772 · JIT
Reference Diagnostics, Inc.
Immunology · 31d
Cleared Mar 24, 2003
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
K030238 · DBM
The Binding Site, Ltd.
Immunology · 60d
Cleared Mar 21, 2003
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
K030397 · MSV
Hycor Biomedical , Ltd.
Immunology · 43d
Cleared Mar 21, 2003
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
K030590 · DHB
Hitachi Chemical Diagnostics, Inc.
Immunology · 24d
Cleared Mar 18, 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
K030626 · DCK
Ortho-Clinical Diagnostics, Inc.
Immunology · 19d
Cleared Feb 24, 2003
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
K024210 · DGC
Beckman Coulter, Inc.
Immunology · 66d
Cleared Feb 24, 2003
BIORAPID MONONUCLEOSIS
K030215 · KTN
Instrumentation Laboratory CO
Immunology · 34d
Cleared Feb 19, 2003
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
K024162 · CFF
Helena Laboratories
Immunology · 64d
Cleared Feb 13, 2003
N LATEX IGA
K024038 · CZP
Dade Behring, Inc.
Immunology · 69d
Cleared Feb 06, 2003
SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
K023593 · JZO
Quest Intl., Inc.
Immunology · 104d
Cleared Feb 06, 2003
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
K024031 · LJM
Theratest Laboratories, Inc.
Immunology · 62d
Cleared Feb 06, 2003
EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
K024151 · MQA
Theratest Laboratories, Inc.
Immunology · 62d
Cleared Feb 06, 2003
OLYMPUS FERRITIN REAGENT
K030124 · DBF
Olympus America, Inc.
Immunology · 23d
Cleared Feb 04, 2003
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP...
K023828 · DCK
Kamiya Biomedical Co.
Immunology · 78d
Cleared Jan 30, 2003
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
K024017 · NCW
Bayer Corp.
Immunology · 57d
Cleared Jan 21, 2003
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI...
K023009 · DFH
The Binding Site, Ltd.
Immunology · 134d
Cleared Jan 21, 2003
FREELITE HUMAN LAMBDA FREE KIT
K023131 · DEH
The Binding Site, Ltd.
Immunology · 134d
Cleared Jan 21, 2003
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER...
K030074 · JIX
Cliniqa Corporation
Immunology · 13d
Cleared Jan 17, 2003
LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114
K024218 · LKJ
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
K024220 · DHN
Bio-Rad
Immunology · 25d
Cleared Jan 17, 2003
LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113
K024232 · LKJ
Bio-Rad
Immunology · 25d
Cleared Jan 15, 2003
RHEUMATOID FACTOR (RF)
K024067 · DHR
Abbott Laboratories
Immunology · 36d