K041361 is an FDA 510(k) clearance for the RANDOX TRI LEVEL CARDIAC CONTROL. 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 September 9, 2004, 111 days after receiving the submission on May 21, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K041361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2004 |
| Decision Date | September 09, 2004 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJY - Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |