hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream— 510(k) K200133

Substantially Equivalent

Safecare Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K200133 for hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream, Substantially Equivalent on 2020-08-13. Applicant: Safecare Biotech (Hangzhou) Co., Ltd..

Clearance details

Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2020-01-21
Decision date: 2020-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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