510(k) K970425 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
EZ SURE URINE DIPSTICK PREGNANCY HOME TEST
| Applicant | Excel Scientific, Inc., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Mar 6, 1997 |
| Received | Feb 4, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970425
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.