510(k) K871341 ยท JIX Calibrator, Multi-Analyte Mixture
QM300 CALIBRATOR A PACK
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, May 21, 1987 |
| Received | Apr 2, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871341
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.