K130500 is an FDA 510(k) clearance for the CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT. This device is classified as a Electrophoretic, Protein Fractionation (Class I - General Controls, product code CEF).
Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on July 26, 2013, 150 days after receiving the submission on February 26, 2013.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1630.
| 510(k) Number | K130500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2013 |
| Decision Date | July 26, 2013 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CEF — Electrophoretic, Protein Fractionation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1630 |