510(k) K061991 ยท GHR Reagent, Platelet Aggregation
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Feb 23, 2007 |
| Received | Jul 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061991
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.