510(k) K983304 ยท CIG Diazo Colorimetry, Bilirubin
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
| Applicant | Synermed Intl., Inc., Lachine, Quebec, CA |
| Decision | Substantially Equivalent, Nov 4, 1998 |
| Received | Sep 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983304
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.