K123253 is an FDA 510(k) clearance for the IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D. This device is classified as a System, Test, Vitamin D (Class II - Special Controls, product code MRG).
Submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on June 18, 2013, 244 days after receiving the submission on October 17, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K123253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2012 |
| Decision Date | June 18, 2013 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | MRG — System, Test, Vitamin D |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1825 |