510(k) K003178 ยท DHA System, Test, Human Chorionic Gonadotropin
ELECSYS HCG AND BETA TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 14, 2000 |
| Received | Oct 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003178
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.