K994278 is an FDA 510(k) clearance for the ACCESS OSTASE IMMUNOENZYMETRIC ASSAY. This device is classified as a Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (Class II - Special Controls, product code CIN).
Submitted by Beckman Coulter, Inc. (San Diego, US). The FDA issued a Cleared decision on March 28, 2000, 99 days after receiving the submission on December 20, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K994278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1999 |
| Decision Date | March 28, 2000 |
| Days to Decision | 99 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 |