The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus B.
| Device ID | K111188 |
| 510k Number | K111188 |
| Device Name: | COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Sarah Baumann |
| Correspondent | Sarah Baumann Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | GGZ |
| Subsequent Product Code | GHS |
| Subsequent Product Code | GKA |
| Subsequent Product Code | GKF |
| Subsequent Product Code | GLY |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJY |
| Subsequent Product Code | KHG |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-27 |
| Decision Date | 2012-05-14 |
| Summary: | summary |