510(k) K964590 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
COLORMATE III
| Applicant | Chromatics Color Sciences Intl., Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Jul 24, 1997 |
| Received | Nov 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964590
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.