510(k) K010052 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
| Applicant | Respironics, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Mar 19, 2001 |
| Received | Jan 8, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K010052
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.