K050231 is an FDA 510(k) clearance for the ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 6, 2005, 161 days after receiving the submission on January 26, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K050231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2005 |
| Decision Date | July 06, 2005 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |