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510(k) K233174

FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream by Assure Tech. (Hangzhou) Co, Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2024
Date Received
September 28, 2023
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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