K001906 is an FDA 510(k) clearance for the ELECSYS INSULIN 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 July 13, 2000, 21 days after receiving the submission on June 22, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K001906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2000 |
| Decision Date | July 13, 2000 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |