Safecare Urinary Tract Infection Test— 510(k) K242767
Substantially EquivalentSafecare 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.. Device class: 1.
Clearance details
- Applicant
- Safecare Biotech (Hangzhou) Co., Ltd.
- Product code
- Code JMT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1510
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code JMT
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Data sourced from openFDA. This site is unofficial and independent of the FDA.