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510(k) K242135

Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream by Nanjing Synthgene Medical Technology Co., Ltd. — Product Code LCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2025
Date Received
July 22, 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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