510(k) K082210 ยท CIG Diazo Colorimetry, Bilirubin
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
| Applicant | Genzyme Diagnostics P.E.I., Inc., Charlottetown, Prin Ed Island, CA |
| Decision | Substantially Equivalent, Dec 16, 2008 |
| Received | Aug 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082210
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.