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510(k) K222850

HAVAb IgG II by Abbott Laboratories — Product Code LOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2023
Date Received
September 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hepatitis A Test (Antibody And Igm Antibody)
Device Class
Class II
Regulation Number
866.3310
Review Panel
MI
Submission Type

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