K033501 is an FDA 510(k) clearance for the MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS). This device is classified as a Calibrator, Multi-analyte Mixture (Class II - Special Controls, product code JIX).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 20, 2003, 15 days after receiving the submission on November 5, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K033501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2003 |
| Decision Date | November 20, 2003 |
| Days to Decision | 15 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |