510(k) K242135— Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

Substantially Equivalent

Nanjing Synthgene Medical Technology Co., Ltd.

Clearance details

Applicant: Nanjing Synthgene Medical Technology Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2024-07-22
Decision date: 2025-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

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