510(k) K963341 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
MIDSTREAM ONESTEP PREGNANCY HOME TEST
| Applicant | Syntron Bioresearch, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 2, 1996 |
| Received | Aug 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963341
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.