K153361 is an FDA 510(k) clearance for the Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators. This device is classified as a System, Test, Vitamin D (Class II - Special Controls, product code MRG).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on April 15, 2016, 147 days after receiving the submission on November 20, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K153361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2015 |
| Decision Date | April 15, 2016 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MRG — System, Test, Vitamin D |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1825 |