510(k) K855040 ยท JIS Calibrator, Primary
SERALYZER TOTAL BILIRUBIN CALIBRATORS
| Applicant | Miles Laboratories, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Jan 22, 1986 |
| Received | Dec 17, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855040
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.