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
121–144 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
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