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
121–144 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 21, 2020
Tina-quant C-Reactive Protein IV
K192072 · DCN
Roche Diagnostics Operations (Rdo)
Immunology · 203d
Cleared Feb 13, 2020
ADVIA Centaur BR
K193489 · MOI
Siemens Healthcare Diagnostics, Inc.
Immunology · 58d
Cleared Jan 15, 2020
ADVIA Centaur Total IgE (tIgE)
K193493 · DGC
Siemens Healthcare Diagnostics, Inc.
Immunology · 29d
Cleared Nov 29, 2019
EliA SymphonyS Immunoassay
K190710 · LLL
Phadia AB
Immunology · 255d
Cleared Nov 22, 2019
ADVIA Centaur CA 15-3 assay
K192777 · MOI
Siemens Healthcare Diagnostics, Inc.
Immunology · 53d
Cleared Nov 08, 2019
CRP Vario
K192118 · DCK
SENTINEL CH. SpA
Immunology · 94d
Cleared Nov 05, 2019
A1AT Genotyping Test
K192858 · PZH
Progenika Biopharma S.A., A Grifols...
Immunology · 32d
Cleared Nov 01, 2019
CAPI 3 Immunotyping, Capillarys 3 Tera
K192095 · CFF
Sebia
Immunology · 88d
Cleared Oct 25, 2019
Maverick RNP Assay and Maverick Diagnostic System
K191085 · LKO
Genalyte, Inc.
Immunology · 184d
Cleared Oct 25, 2019
ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
K191807 · NXO
ALPCO
Immunology · 112d
Cleared Oct 22, 2019
Lumpipulse G CA19-9-N
K191973 · NIG
Fujirebio Dianostics, Inc.
Immunology · 90d
Cleared Sep 24, 2019
Buhlmann fCAL turbo and CALEX Cap
K191718 · NXO
Buhlmann Laboratories AG
Immunology · 90d
Cleared Sep 06, 2019
Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
K182886 · GKZ
Beckman Coulter
Immunology · 326d
Cleared Sep 04, 2019
Human IgA liquid reagent kit for Use on SPAPlus
K192116 · CFN
The Binding Site Group , Ltd.
Immunology · 29d
Cleared Aug 19, 2019
Optilite IgA Kit
K191985 · CFN
The Binding Site Group , Ltd.
Immunology · 25d
Cleared Jul 31, 2019
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent...
K191510 · DHB
Hycor Biomedical
Immunology · 55d
Cleared Jul 15, 2019
Optilite IgM Kit
K191635 · CFN
The Binding Site Group , Ltd.
Immunology · 26d
Cleared Jul 10, 2019
Calprest, EasyCal
K191589 · NXO
Eurospital S.P.A.
Immunology · 26d
Cleared Jul 10, 2019
CalprestNG, EasyCal
K191592 · NXO
Eurospital S.P.A.
Immunology · 26d
Cleared Jun 27, 2019
Human IgM Kit for use on SPAPlus
K191465 · CFN
The Binding Site Group , Ltd.
Immunology · 24d
Cleared Jun 25, 2019
BUHLMANN fCAL turbo
K190784 · NXO
Buhlmann Laboratories AG
Immunology · 90d
Cleared May 28, 2019
Optilite IgM CSF Kit
K190686 · CFN
The Binding Site Group , Ltd.
Immunology · 71d
Cleared May 14, 2019
ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen...
K190315 · DHB
Phadia AB
Immunology · 90d
Cleared May 03, 2019
N Latex FLC kappa, N Latex FLC lambda
K190879 · DFH
Siemens Healthcare Diagnostics...
Immunology · 29d