K050387 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 25, 2005, 69 days after receiving the submission on February 15, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K050387 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2005 |
| Decision Date | April 25, 2005 |
| Days to Decision | 69 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |