The following data is part of a premarket notification filed by Sebia, Inc. with the FDA for Capillary's Immunotyping (pn 2100).
| Device ID | K042939 |
| 510k Number | K042939 |
| Device Name: | CAPILLARY'S IMMUNOTYPING (PN 2100) |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | Sebia, Inc. 13805 WATERLOO Chelsea, MI 48118 |
| Contact | Borek Janik |
| Correspondent | Borek Janik Sebia, Inc. 13805 WATERLOO Chelsea, MI 48118 |
| Product Code | DFH |
| Subsequent Product Code | CEF |
| Subsequent Product Code | CFF |
| Subsequent Product Code | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-25 |
| Decision Date | 2005-06-27 |