510(k) K972608 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Aug 4, 1997 |
| Received | Jun 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972608
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2023 | Randox Laboratories Ltd. Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2682
Control Level 1 Open, Classified |
JJY | None listed |
| Jan 5, 2023 | Randox Laboratories Ltd. Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2683 Open, Classified |
JJY | None listed |
| Jan 5, 2023 | Randox Laboratories Ltd. Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2684 Open, Classified |
JJY | None listed |
| Jun 13, 2018 | Randox Laboratories Ltd. Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682 Terminated |
JJY | None listed |
| Jun 13, 2018 | Randox Laboratories Ltd. Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683 Terminated |
JJY | None listed |
| Jun 13, 2018 | Randox Laboratories Ltd. Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684 Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.