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
145–168 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 21, 2019
ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow...
K183592 · PWD
Beckman Coulter
Immunology · 90d
Cleared Mar 19, 2019
AP3600 Automated Instrument
K182793 · DHB
Hitachi Chemical Diagnostics, Inc.
Immunology · 169d
Cleared Mar 01, 2019
EliA Celikey IgG Immunoassay
K181871 · MVM
Phadia AB
Immunology · 232d
Cleared Feb 28, 2019
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue...
K183313 · MVM
Euroimmun Us, Inc.
Immunology · 91d
Cleared Jan 23, 2019
Optilite IgA CSF Kit
K183151 · CFN
The Binding Site Group , Ltd.
Immunology · 70d
Cleared Dec 26, 2018
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin...
K182698 · NXO
DiaSorin, Inc.
Immunology · 90d
Cleared Dec 24, 2018
EliA SmDP Immunoassay
K183007 · LKP
Phadia AB
Immunology · 54d
Cleared Dec 18, 2018
EliA RF IgM Immunoassay
K182747 · DHR
Phadia AB
Immunology · 81d
Cleared Dec 04, 2018
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture...
K182479 · DHB
Hycor Biomedical
Immunology · 85d
Cleared Nov 27, 2018
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
K182353 · LJM
Phadia AB
Immunology · 90d
Cleared Nov 23, 2018
Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
K180607 · PCG
Kronus, Inc.
Immunology · 261d
Cleared Nov 05, 2018
Tina-quant Transferrin ver.2 (urine application)
K182095 · DDG
Roche Diagnostics Operations (Rdo)
Immunology · 94d
Cleared Nov 01, 2018
N Latex FLC kappa assay, N Latex FLC lambda assay
K182098 · DFH
Siemens Healthcare Diagnostics...
Immunology · 90d
Cleared Oct 19, 2018
Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by...
K180202 · DBL
Immuno Concepts, N.A. , Ltd.
Immunology · 268d
Cleared Oct 16, 2018
QUANTA Flash Calprotectin and Fecal Extraction Device
K180971 · NXO
Inova Diagnostics, Inc.
Immunology · 186d
Cleared Aug 23, 2018
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
K173732 · DFH
The Binding Site Group , Ltd.
Immunology · 260d
Cleared Jul 13, 2018
EliA M2 Immunoassay
K181556 · DBM
Phadia AB
Immunology · 30d
Cleared Jun 26, 2018
Diazyme Human Kappa Free Light Chain Assay
K181438 · DFH
Diazyme Laboratories, Inc.
Immunology · 25d
Cleared Jun 25, 2018
QUANTA Flash HMGCR Reagents
K180975 · LLL
Inova Diagnostics, Inc.
Immunology · 73d
Cleared Jun 25, 2018
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
K181329 · MSV
Phadia AB
Immunology · 38d
Cleared Jun 22, 2018
Elecsys CA 15-3 II
K181492 · MOI
Roche Diagnostics
Immunology · 16d
Cleared Jun 05, 2018
ImmuGlo HEp-2 Elite IFA
K172745 · DHN
Immco Diagnostics, Inc.
Immunology · 266d
Cleared Jun 04, 2018
BUHLMANN fCAL ELISA
K181012 · NXO
Buhlmann Laboratories AG
Immunology · 48d
Cleared May 24, 2018
EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS...
K172582 · MOB
Euroimmun Us, Inc.
Immunology · 269d