510(k) K912201 ยท JBY Aggregometer, Platelet, Photo-Optical Scanning
PACKS-4 (TM) ANALYZER
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Aug 16, 1991 |
| Received | May 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912201
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.