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FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream

Assure Tech. (Hangzhou) Co, Ltd. · Class II · Cleared Feb 5, 2024

K-numberK233174
Device nameFaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream
ApplicantAssure Tech. (Hangzhou) Co, Ltd.
Product codeLCX
Device classClass II
Decision dateFeb 5, 2024
DecisionSubstantially Equivalent
Regulation862.1155
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Source

View the full FDA submission: accessdata.fda.gov

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