K936016 is an FDA 510(k) clearance for the QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA). This device is classified as a Assay, Erythropoietin (Class II - Special Controls, product code GGT).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 19, 1994, 215 days after receiving the submission on December 16, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7250.
| 510(k) Number | K936016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1993 |
| Decision Date | July 19, 1994 |
| Days to Decision | 215 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGT — Assay, Erythropoietin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7250 |