510(k) K142609 ยท LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Dec 18, 2014 |
| Received | Sep 16, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142609
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.