K022053 is an FDA 510(k) clearance for the HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134. This device is classified as a Electrophoretic Separation, Lipoproteins (Class I - General Controls, product code JHO).
Submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on July 12, 2002, 18 days after receiving the submission on June 24, 2002.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K022053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2002 |
| Decision Date | July 12, 2002 |
| Days to Decision | 18 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JHO — Electrophoretic Separation, Lipoproteins |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |