510(k) K852068 ยท JIS Calibrator, Primary
TOTAL BILIRUBIN STANDARDS
| Applicant | Data Medical Associates, Inc., Arlington TX, US |
| Decision | Substantially Equivalent, May 31, 1985 |
| Received | May 10, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852068
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.