The following data is part of a premarket notification filed by Sebia with the FDA for It/if Control.
| Device ID | K101863 |
| 510k Number | K101863 |
| Device Name: | IT/IF CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
| Product Code | JJY |
| Subsequent Product Code | CEF |
| Subsequent Product Code | CFF |
| Subsequent Product Code | DEH |
| Subsequent Product Code | DFH |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-02 |
| Decision Date | 2011-11-07 |