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510(k) K252424

Anti-HCV Next by Abbott Laboratories — Product Code MZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2026
Date Received
August 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Device Class
Class II
Regulation Number
866.3169
Review Panel
MI
Submission Type

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