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
73–96 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
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