The following data is part of a premarket notification filed by Sebia with the FDA for Capillarys Immunotyping, Capillarys 2 Instrument, It/if Control, Capillarys 2 Flex Piercing Instrument.
| Device ID | K130500 |
| 510k Number | K130500 |
| Device Name: | CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT |
| Classification | Electrophoretic, Protein Fractionation |
| Applicant | SEBIA 1705 CORPORATE DRIVE SUITE 400 Duluth, GA 30093 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson SEBIA 1705 CORPORATE DRIVE SUITE 400 Duluth, GA 30093 |
| Product Code | CEF |
| Subsequent Product Code | CFF |
| Subsequent Product Code | DEH |
| Subsequent Product Code | DFH |
| CFR Regulation Number | 862.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-26 |
| Decision Date | 2013-07-26 |
| Summary: | summary |