K003409 is an FDA 510(k) clearance for the ELECSYS FSH CALSET II. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 26, 2001, 85 days after receiving the submission on November 2, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K003409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2000 |
| Decision Date | January 26, 2001 |
| Days to Decision | 85 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |