510(k) K900017 ยท JPK Mixture, Hematology Quality Control
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jan 29, 1990 |
| Received | Jan 2, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900017
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.