K951536 is an FDA 510(k) clearance for the HYDRAGEL PROTEIN(E) KIT. This device is classified as a Electrophoretic, Protein Fractionation (Class I - General Controls, product code CEF).
Submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on June 30, 1995, 88 days after receiving the submission on April 3, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1630.
| 510(k) Number | K951536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1995 |
| Decision Date | June 30, 1995 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CEF — Electrophoretic, Protein Fractionation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1630 |