K152343 is an FDA 510(k) clearance for the Direct Bilirubin. This device is classified as a Enzymatic Method, Bilirubin (Class II - Special Controls, product code JFM).
Submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on February 16, 2016, 181 days after receiving the submission on August 19, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K152343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2015 |
| Decision Date | February 16, 2016 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFM - Enzymatic Method, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |