K931666 is an FDA 510(k) clearance for the QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY. 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 20, 1993, 105 days after receiving the submission on April 6, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7250.
| 510(k) Number | K931666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1993 |
| Decision Date | July 20, 1993 |
| Days to Decision | 105 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 |