K200475 is an FDA 510(k) clearance for the IDS-iSYS Ostase BAP. This device is classified as a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II - Special Controls, product code CIN).
Submitted by Immunodiagnostic Systems , Ltd. (Boldon, GB). The FDA issued a Cleared decision on September 30, 2020, 217 days after receiving the submission on February 26, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K200475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2020 |
| Decision Date | September 30, 2020 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |