510(k) K002148 ยท DHA System, Test, Human Chorionic Gonadotropin
ELECSYS HCG TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 22, 2000 |
| Received | Jul 17, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002148
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.