K232904 is an FDA 510(k) clearance for the Access Ostase. This device is classified as a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II - Special Controls, product code CIN).
Submitted by Beckman Coulter (Chaska, US). The FDA issued a Cleared decision on April 15, 2024, 210 days after receiving the submission on September 18, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K232904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2023 |
| Decision Date | April 15, 2024 |
| Days to Decision | 210 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 |