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
769–792 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
K024217 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219 · LKP
Bio-Rad
Immunology · 23d