K110846 is an FDA 510(k) clearance for the RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2. This device is classified as a Urinalysis Controls (assayed And Unassayed) (Class I - General Controls, product code JJW).
Submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on September 30, 2011, 186 days after receiving the submission on March 28, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K110846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2011 |
| Decision Date | September 30, 2011 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJW - Urinalysis Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |