K003969 is an FDA 510(k) clearance for the ELECSYS CA 125 II CALSET. This device is classified as a Calibrator, Primary (Class II - Special Controls, product code JIS).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 12, 2001, 21 days after receiving the submission on December 22, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K003969 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2000 |
| Decision Date | January 12, 2001 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |