K002353 is an FDA 510(k) clearance for the ELECSYS CA 15-3 CALCHECK. 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 August 10, 2000, 8 days after receiving the submission on August 2, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K002353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2000 |
| Decision Date | August 10, 2000 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |