The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids Isys 1,25 Dihydroxy Vitamin D, Ids-isys, 1,25 Dihydroxy Vitamin D Control Set, And Ids Isys 1,25 Dihydroxy Vitamin D.
| Device ID | K123253 |
| 510k Number | K123253 |
| Device Name: | IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D |
| Classification | System, Test, Vitamin D |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Contact | Mick Fenton |
| Correspondent | Mick Fenton IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-17 |
| Decision Date | 2013-06-18 |