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
97–120 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 26, 2021
Aptiva Celiac Disease IgG Reagent
K200230 · MVM
Inova Diagnostics, Inc.
Immunology · 574d
Cleared Jul 14, 2021
N Latex FLC kappa, N Latex FLC lambda
K193047 · DFH
Siemens Healthcare Diagnostics...
Immunology · 621d
Cleared Jul 14, 2021
EliA SmDP-S
K202067 · LKP
Phadia AB
Immunology · 352d
Cleared Jun 16, 2021
Aptiva Celiac Disease IgA Reagent
K193604 · MVM
Inova Diagnostics, Inc.
Immunology · 541d
Cleared May 13, 2021
A1AT Genotyping Test
K211115 · PZH
Progenika Biopharma S.A., A Grifols...
Immunology · 29d
Cleared Jan 08, 2021
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
K201778 · QAT
Abbott Laboratories
Immunology · 192d
Cleared Dec 23, 2020
Helix Genetic Health Risk App for late-onset Alzheimer’s disease
K192073 · PTA
Helix Opco, LLC
Immunology · 509d
Cleared Dec 11, 2020
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
K192916 · KTL
Inova Diagnostics, Inc.
Immunology · 423d
Cleared Sep 28, 2020
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical...
K201814 · OYE
Becton, Dickinson and Company
Immunology · 89d
Cleared Sep 17, 2020
EUROIMMUN Anti-BP230-CF ELISA (IgG)
K193115 · OEG
Euroimmun Us, Inc.
Immunology · 310d
Cleared Sep 04, 2020
Lumipulse G CA15-3
K192524 · MOI
Fujirebio Diagnostics,Inc.
Immunology · 357d
Cleared Jun 26, 2020
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200...
K193525 · CZP
HORIBA ABX SAS
Immunology · 190d
Cleared Jun 26, 2020
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus
K200825 · DHB
Hycor Biomedical
Immunology · 88d
Cleared Jun 25, 2020
Yumizen C1200 CRP
K192028 · DCK
HORIBA ABX SAS
Immunology · 335d
Cleared May 20, 2020
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
K192727 · DHR
Kamiya Biomedical Company
Immunology · 236d
Cleared May 14, 2020
Lumipulse G CA19-9-N
K200997 · NIG
Fujirebio Diagnostics,Inc.
Immunology · 28d
Cleared May 01, 2020
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal)...
K200279 · DHB
Phadia AB
Immunology · 87d
Cleared Apr 13, 2020
ADVIA Centaur CEA Assay
K200215 · DHX
Siemens Healthcare Disgnostics, Inc.
Immunology · 76d
Cleared Apr 06, 2020
ADVIA Centaur CA 125II
K200199 · LTK
Siemens Healthcare Diagnostics, Inc.
Immunology · 70d
Cleared Mar 16, 2020
Transferrin
K190495 · DDG
Biosystems S.A.
Immunology · 382d
Cleared Mar 06, 2020
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid...
K191562 · DBF
HORIBA ABX SAS
Immunology · 267d
Cleared Feb 27, 2020
Elecsys Anti-TSHR
K193313 · JZO
Roche Diagnostics
Immunology · 90d
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