510(k) K914946 ยท GKP Instrument, Coagulation, Automated
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jan 13, 1992 |
| Received | Oct 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914946
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.