510(k) K855035 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
CALIBRATION REFERENCE I & II
| Applicant | Integrated Medical Systems Int'L., Inc., Mc Allen TX, US |
| Decision | Substantially Equivalent, Mar 17, 1986 |
| Received | Dec 17, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K855035
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.