510(k) K011052 ยท JMM Column Chromatography & Color Development, Hydroxyproline
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
| Applicant | Ostex Intl., Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Jul 30, 2001 |
| Received | Apr 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011052
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.