510(k) K921465 ยท GKP Instrument, Coagulation, Automated
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jun 29, 1992 |
| Received | Mar 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921465
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.