K242802
- 510(k) number
- K242802
- Device name
- CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
- Applicant
- Hangzhou Clongene Biotech Co., Ltd. CN
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2024-11-08
- Date received
- 2024-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242802.pdf
Official FDA record: K242802
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.