K042519 is an FDA 510(k) clearance for the GAMMA-B 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 December 1, 2004, 76 days after receiving the submission on September 16, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K042519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2004 |
| Decision Date | December 01, 2004 |
| Days to Decision | 76 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 |