510(k) K031608 ยท JIX Calibrator, Multi-Analyte Mixture
RANDOX LIQUID PROTEIN CALIBRATOR
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, GB |
| Decision | Substantially Equivalent, Aug 8, 2003 |
| Received | May 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031608
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2018 | Randox Laboratories Ltd. SP CAL (LIQ), REF IT2692
This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution. Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.