510(k) K981512 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
| Applicant | Skd, Inc. A Beckman Coulter Co., Palo Alto CA, US |
| Decision | Substantially Equivalent, May 28, 1998 |
| Received | Apr 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981512
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.