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510(k) K241394

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip by Andon Health Co, Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2024
Date Received
May 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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