K232864

Substantially Equivalent

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

Applicant: Nantong Egens Biotechnology Co., Ltd.
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.