510(k) K884224 ยท CIG Diazo Colorimetry, Bilirubin
TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS
| Applicant | A-Kem, Inc., Clifton NJ, US |
| Decision | Substantially Equivalent, Dec 15, 1988 |
| Received | Oct 6, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884224
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.