510(k) K031604 ยท NOZ Assay, 1,5-Anhydroglucitol (15ag)
GLYCOMARK
| Applicant | Tomen America, Inc., New York NY, US |
| Decision | Substantially Equivalent, Sep 22, 2003 |
| Received | May 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031604
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.