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
25–48 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Feb 23, 2024
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
K231601 · DFH
Sebia
Immunology · 267d
Cleared Feb 06, 2024
BÜHLMANN fCAL® turbo and CALEX® Cap
K232057 · NXO
B?hlmann Laboratories AG
Immunology · 210d