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
25–48 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 08, 2025
Elecsys Phospho-Tau (181P) Plasma
K252163 · SET
Roche Diagnostics
Immunology · 90d
Cleared Sep 19, 2025
Alegria Flash ENA Screen
K250408 · LLL
Zeus Scientific
Immunology · 218d
Cleared Jun 20, 2025
Atellica IM Thyroglobulin (Tg)
K242981 · MSW
Siemens Healthcare Diagnostics, Inc.
Immunology · 267d
Not Cleared Jun 12, 2025
APO-Easy Genotyping kit
DEN240032 · SFC
Firalis SA
Immunology · 356d
Cleared May 23, 2025
Optilite® Freelite Mx Kappa Free Kit
K250549 · DFH
The Binding Site Group , Ltd.
Immunology · 87d
Cleared May 16, 2025
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
K242706 · SET
Fujirebio Diagnostics,Inc.
Immunology · 249d
Cleared May 07, 2025
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed)
K243776 · MOB
Zeus Scientific
Immunology · 149d
Cleared Apr 23, 2025
NOVEOS Specific IgE (sIgE) Assay
K242531 · DHB
Hycor Biomedical
Immunology · 240d
Cleared Apr 18, 2025
K-ASSAY CRP (Ver.2)
K242170 · DCK
Kamiya Biomedical Company, LLC
Immunology · 268d
Cleared Jan 07, 2025
GlutenID Celiac Genetic Health Risk Test
K241456 · PTA
Targeted Genomics, LLC
Immunology · 230d
Cleared Dec 17, 2024
Aptiva APS IgG Reagent
K223093 · MID
Inova Diagnostics, Inc.
Immunology · 809d
Cleared Aug 09, 2024
Access TPO Antibody
K240469 · JZO
Beckman Coulter, Inc.
Immunology · 171d
Cleared Jul 03, 2024
Access Thyroglobulin Antibody II
K240996 · JNL
Beckman Coulter, Inc.
Immunology · 83d
Cleared Jul 03, 2024
Access sTfR
K240987 · DDG
Beckman Coulter, Inc.
Immunology · 84d
Cleared Jun 28, 2024
Access Thyroglobulin
K240927 · MSW
Beckman Coulter, Inc.
Immunology · 85d
Cleared Jun 07, 2024
Access Thyroglobulin
K241423 · MSW
Beckman Coulter, Inc.
Immunology · 18d
Cleared May 31, 2024
Kenota 1 Total IgE
K231151 · DGC
Kenota, Inc.
Immunology · 403d
Cleared May 10, 2024
Access OV Monitor
K240479 · LTK
Beckman Coulter, Inc.
Immunology · 80d
Cleared May 09, 2024
Access BR Monitor
K240403 · MOI
Beckman Coulter, Inc.
Immunology · 90d
Cleared May 03, 2024
AUTION EYE AI-4510 Urine Particle Analysis System
K232416 · LKM
Arkray, Inc.
Immunology · 266d
Cleared May 01, 2024
VIDAS TBI (GFAP, UCH-L1)
K240279 · QAT
bioMerieux, Inc.
Immunology · 90d
Cleared Mar 27, 2024
i-STAT TBI Cartridge with the i-STAT Alinity System
K234143 · QAT
Abbott Point of Care
Immunology · 89d
Cleared Mar 20, 2024
Access Ferritin
K234052 · JMG
Beckman Coulter, Inc.
Immunology · 90d
Cleared Mar 13, 2024
IMMULITE® 2000 BR-MA
K233946 · MOI
Siemens Healthcare Diagnostics...
Immunology · 90d