K200986 is an FDA 510(k) clearance for the OPTI® B-Lac Cassette. This device is classified as a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II - Special Controls, product code CHL).
Submitted by Opti Medical Systems, Inc. (Roswell, US). The FDA issued a Cleared decision on August 2, 2021, 474 days after receiving the submission on April 15, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.
| 510(k) Number | K200986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2020 |
| Decision Date | August 02, 2021 |
| Days to Decision | 474 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 |