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MOI

System, Test, Immunological, Antigen, Tumor

Product code
MOI
Device name
System, Test, Immunological, Antigen, Tumor
Device class
Class 2
21 CFR
21 CFR 866.6010
Medical specialty
Immunology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
28 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-05-09.

NumberDecision dateApplicantDevice nameSummary
K2404032024-05-09Beckman Coulter, Inc.Access BR MonitorPDF
K2339462024-03-13Siemens Healthcare Diagnostics Product…IMMULITE® 2000 BR-MAPDF

2 summaries are archived here for direct download.

Official FDA classification page: MOI
Classification and pathway per current FDA publications. Data from openFDA (CC0).