510(k) K970008 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
ADVANCED QUALITY PREGNANCY TEST
| Applicant | Bionike, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Feb 18, 1997 |
| Received | Jan 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970008
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.