510(k) K992397 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
| Applicant | Cenogenics Corp., Morganville NJ, US |
| Decision | Substantially Equivalent, Aug 26, 1999 |
| Received | Jul 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992397
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.