K051110 is an FDA 510(k) clearance for the 1,25-DIHYDROXY VITAMIN D EIA. 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 July 6, 2005, 65 days after receiving the submission on May 2, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K051110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2005 |
| Decision Date | July 06, 2005 |
| Days to Decision | 65 days |
| Submission Type | Abbreviated |
| 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 |