CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette— 510(k) K242802
Substantially EquivalentHangzhou Clongene Biotech Co., Ltd.
FDA 510(k) clearance K242802 for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette, Substantially Equivalent on 2024-11-08. Applicant: Hangzhou Clongene Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou Clongene 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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More clearances from Hangzhou Clongene Biotech Co., Ltd.
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Data sourced from openFDA. This site is unofficial and independent of the FDA.