K033937 is an FDA 510(k) clearance for the ELECSYS PRECICONTROL MULTIANALYTE. 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 January 7, 2004, 19 days after receiving the submission on December 19, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K033937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2003 |
| Decision Date | January 07, 2004 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |