510(k) K190705— WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream

Substantially Equivalent

Wholepower Biotech Co., Ltd.

Clearance details

Applicant: Wholepower Biotech Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2019-03-19
Decision date: 2019-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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