510(k) K242802 ยท NGL Test, Opiates, Over The Counter
CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
| Applicant | Hangzhou Clongene Biotech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Nov 8, 2024 |
| Received | Sep 17, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242802
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.