510(k) K112395 ยท LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Sep 9, 2011 |
| Received | Aug 19, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112395
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.