Safecare Urinary Tract Infection Test— 510(k) K242767

Substantially Equivalent

Safecare Biotech (Hangzhou) Co., Ltd.

FDA 510(k) clearance K242767 for Safecare Urinary Tract Infection Test, Substantially Equivalent on 2025-01-10. Applicant: Safecare Biotech (Hangzhou) Co., Ltd..

Clearance details

Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
Product code: Code JMT
Advisory panel: Clinical Chemistry
Date received: 2024-09-13
Decision date: 2025-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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