K970718 is an FDA 510(k) clearance for the QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA). This device is classified as a Immunochemical, Transferrin (Class II - Special Controls, product code JNM).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 27, 1997, 90 days after receiving the submission on February 26, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K970718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1997 |
| Decision Date | May 27, 1997 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JNM — Immunochemical, Transferrin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |