510(k) K001687 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
COLORMATE TLC BILITEST SYSTEM
| Applicant | Chromatics Color Sciences Intl., Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Sep 13, 2001 |
| Received | Jun 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001687
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.