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
97–120 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 13, 2021
EliA Rib-P
K202540 · MQA
Phadia AB
Immunology · 376d
Cleared Sep 13, 2021
EliA RNA Pol III
K202541 · NYO
Phadia AB
Immunology · 376d
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