510(k) K931756 ยท GGT Assay, Erythropoietin
QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS
| Applicant | R&D Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 21, 1994 |
| Received | Apr 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931756
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2022 | R & D Systems, Inc. Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095 Terminated |
GGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.