AllTest Fentanyl Urine Test Cassette— 510(k) K233417
Substantially EquivalentHangzhou AllTest Biotech Co., Ltd.
FDA 510(k) clearance K233417 for AllTest Fentanyl Urine Test Cassette, Substantially Equivalent on 2023-10-26. Applicant: Hangzhou AllTest Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou AllTest Biotech 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
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- K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
More clearances from Hangzhou AllTest Biotech Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.