K170938 is an FDA 510(k) clearance for the CalSet IGF-1. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 26, 2017, 27 days after receiving the submission on March 30, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K170938 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2017 |
| Decision Date | April 26, 2017 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |