EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II— 510(k) K232864

Substantially Equivalent

Nantong Egens Biotechnology Co., Ltd.

FDA 510(k) clearance K232864 for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II, Substantially Equivalent on 2024-01-26. Applicant: Nantong Egens Biotechnology Co., Ltd..

Clearance details

Applicant: Nantong Egens Biotechnology Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2023-09-15
Decision date: 2024-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nantong, CN

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