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
73–96 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 21, 2023
Quantia IgE
K214068 · DGC
Biokit, S.A.
Immunology · 421d
Cleared Dec 12, 2022
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
K221355 · LTK
Ortho-Clinical Diagnostics
Immunology · 216d
Cleared Dec 07, 2022
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
K221842 · QSE
Roche Diagnostics
Immunology · 166d
Cleared Nov 18, 2022
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
K210623 · DFH
Sebia
Immunology · 626d
Cleared Nov 04, 2022
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
K201256 · DCK
Procise Diagnostics
Immunology · 907d
Cleared Oct 27, 2022
AlphaID™ At Home Genetic Health Risk Service
K221420 · PTA
Progenika Biopharma S.A., A Grifols...
Immunology · 164d
Cleared Oct 13, 2022
SPIFE A1AT kit
K213396 · OBZ
Helena Laboratories, Corp.
Immunology · 360d
Cleared Sep 15, 2022
Elecsys AFP
K220176 · LOJ
Roche Diagnostics
Immunology · 237d
Cleared Sep 08, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K211648 · DFH
Diazyme Laboratories, Inc.
Immunology · 468d
Cleared Aug 04, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K220001 · DFH
Diazyme Laboratories, Inc.
Immunology · 212d
Cleared Aug 03, 2022
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP...
K212181 · DHB
Phadia AB
Immunology · 386d
Cleared Jul 29, 2022
DiviTum TKa
K202852 · QTE
Biovica International AB
Immunology · 669d
Cleared Jul 27, 2022
EliA Ro52, EliA Ro60
K210902 · LKJ
Phadia AB
Immunology · 488d
Cleared Jul 26, 2022
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
K213858 · NXO
DiaSorin, Inc.
Immunology · 228d
Cleared Jun 15, 2022
VITROS AFP
K213626 · LOJ
Ortho-Clinical Diagnostics
Immunology · 210d
Not Cleared May 04, 2022
Lumipulse G ß-Amyloid Ratio (1-42/1-40)
DEN200072 · QSE
Fujirebio Diagnostics,Inc.
Immunology · 530d
Cleared Apr 29, 2022
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
K201956 · DHN
Zeus Scientific, Inc.
Immunology · 654d
Cleared Mar 23, 2022
Total Immunoglobulin E (IgE)
K220178 · DGC
Beckman Coulter, Inc.
Immunology · 61d
Cleared Mar 02, 2022
N Latex FLC kappa, N Latex FLC lambda
K212379 · DFH
Siemens Healthcare Diagnostics...
Immunology · 212d
Cleared Feb 18, 2022
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent...
K220162 · DHB
Hycor Biomedical
Immunology · 29d
Cleared Nov 12, 2021
HYDRASHIFT 2/4 isatuximab
K203184 · CFF
Sebia
Immunology · 381d
Cleared Oct 29, 2021
N Latex FLC kappa, N Latex FLC lambda
K201496 · DFH
Siemens Healthcare Diagnostics...
Immunology · 511d
Cleared Oct 18, 2021
Allergen-Specific IgE Assay 12 Allergen Bundle
K193613 · DHB
Hitachi Chemical Diagnostics, Inc.
Immunology · 662d
Cleared Sep 14, 2021
LIAISON Ferritin
K193650 · DBF
DiaSorin, Inc.
Immunology · 624d