K111188 is an FDA 510(k) clearance for the COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B. This device is classified as a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II - Special Controls, product code CHL).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 14, 2012, 383 days after receiving the submission on April 27, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.
| 510(k) Number | K111188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2011 |
| Decision Date | May 14, 2012 |
| Days to Decision | 383 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1120 |