510(k) K020368 ยท DJG Enzyme Immunoassay, Opiates
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT)
| Applicant | Lin-Zhi International, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jun 4, 2002 |
| Received | Feb 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020368
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.