510(k) K921363 ยท GKP Instrument, Coagulation, Automated
CASCADE 480
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jun 9, 1992 |
| Received | Mar 20, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921363
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.