510(k) K930104 ยท JIX Calibrator, Multi-Analyte Mixture
ACE CLINICAL CHEMISTRY SYSTEM
| Applicant | Schiapparelli Biosystems, Inc., Fairfield NJ, US |
| Decision | Substantially Equivalent, Aug 23, 1993 |
| Received | Jan 11, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930104
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2006 | Alfa Wassermann, Inc Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control. Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.