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
145–168 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared May 02, 2019
HYDRASHIFT 2/4 daratumumab
K190851 · CFF
Sebia
Immunology · 30d
Cleared Apr 17, 2019
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · DHR
Inova Diagnostics, Inc.
Immunology · 90d
Cleared CT 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 CT 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