SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette— 510(k) K240654
Substantially EquivalentSafecare Biotech (Hangzhou) Co., Ltd.
FDA 510(k) clearance K240654 for SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette, Substantially Equivalent on 2024-04-10. Applicant: Safecare Biotech (Hangzhou) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Safecare Biotech (Hangzhou) Co., Ltd.
- Product code
- Code NGL
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
Recent devices under product code NGL
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- K250067 — Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
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- K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
More clearances from Safecare Biotech (Hangzhou) Co., Ltd.
view all- K242767 — Safecare Urinary Tract Infection Test
- K202453 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
- K200133 — hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
- K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
- K191924 — SAFECARE® THC Urine Strip Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.