K130337 is an FDA 510(k) clearance for the RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on June 19, 2013, 128 days after receiving the submission on February 11, 2013.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K130337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2013 |
| Decision Date | June 19, 2013 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| 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 |