K043095 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS ELECSYS AFP 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 November 23, 2004, 14 days after receiving the submission on November 9, 2004.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K043095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2004 |
| Decision Date | November 23, 2004 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |