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510(k) K250117

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette by Assure Tech., LLC — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2025
Date Received
January 16, 2025
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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  • K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (December 20, 2024)
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  • K232715 — Distinct® Digital Pregnancy Test (May 31, 2024)
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