510(k) K003609 ยท NEO System, Test, Osteocalcin
N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
| Applicant | Osteometer Biotech A/S, Herlev, DK |
| Decision | Substantially Equivalent, May 16, 2001 |
| Received | Nov 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003609
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.