K100307 is an FDA 510(k) clearance for the GELSCAN, MODEL 1206. This device is classified as a Electrophoretic, Lactate Dehydrogenase Isoenzymes (Class II - Special Controls, product code CFE).
Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on August 31, 2010, 209 days after receiving the submission on February 3, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1445.
| 510(k) Number | K100307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2010 |
| Decision Date | August 31, 2010 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1445 |