K011113 is an FDA 510(k) clearance for the HYDRAGEL ISO-PAL K20 (PN 3022). This device is classified as a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II - Special Controls, product code CIN).
Submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on June 13, 2001, 63 days after receiving the submission on April 11, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K011113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2001 |
| Decision Date | June 13, 2001 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |