510(k) K945951 ยท JHI Visual, Pregnancy Hcg, Prescription Use
QUIKPAC II, ONE STEP HCG COMBO KIT
| Applicant | Syntron Bioresearch, Inc., Vista CA, US |
| Decision | Substantially Equivalent, Feb 8, 1995 |
| Received | Dec 6, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945951
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.