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

Name: FDA 510(k) clearance K200133
Creator: U.S. Food and Drug Administration
Published: 2020-08-13

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.. Device class: 2.

Clearance details

Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2020-01-21
Decision date: 2020-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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