510(k) K053153 ยท JIX Calibrator, Multi-Analyte Mixture
RANDOX CALIBRATION SERUM
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Jan 13, 2006 |
| Received | Nov 10, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053153
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2024 | Randox Laboratories Ltd. Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests. Open, Classified |
JIX | None listed |
| Jan 18, 2024 | Randox Laboratories Ltd. Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532) Open, Classified |
JIX | None listed |
| Jan 18, 2024 | Randox Laboratories Ltd. Calibration Serum Level 3
CAL2351 Open, Classified |
JIX | None listed |
| Jan 18, 2024 | Randox Laboratories Ltd. Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays
Catalog Number: CAL2351 Open, Classified |
JIX | None listed |
| Mar 29, 2021 | Randox Laboratories Ltd. Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator.
Catalogue Number: CAL2351 Terminated |
JIX | None listed |
| Jul 12, 2019 | Randox Laboratories Ltd. This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The c Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.