510(k) K192123— HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream

Substantially Equivalent

Qingdao Hightop Biotech Co., Ltd.

Clearance details

Applicant: Qingdao Hightop Biotech Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2019-08-06
Decision date: 2019-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qingdao, CN

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