510(k) K111143 ยท CIG Diazo Colorimetry, Bilirubin
POLY-CHEM 90 TOTAL BILIRUBIN
| Applicant | Polymedco, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Sep 1, 2011 |
| Received | Apr 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111143
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.