510(k) K992845 ยท JIX Calibrator, Multi-Analyte Mixture
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT
| Applicant | Elan Holdings, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Oct 18, 1999 |
| Received | Aug 24, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992845
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.