K122126 is an FDA 510(k) clearance for the DIRECT LDL/HDL CHOLESTEROL CALIBRATOR. This device is classified as a Calibrator, Primary (Class II - Special Controls, product code JIS).
Submitted by Randox Laboratories Limited (Crumlin, County Antrim, GA). The FDA issued a Cleared decision on August 14, 2012, 27 days after receiving the submission on July 18, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K122126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2012 |
| Decision Date | August 14, 2012 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIS - Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |