510(k) K152643 ยท LDJ Enzyme Immunoassay, Cannabinoids
EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana
| Applicant | Nantong Egens Biotech Co., Ltd., Nantong, CN |
| Decision | Substantially Equivalent, Nov 2, 2015 |
| Received | Sep 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152643
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.