The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids-isys 25-hydroxy Vitamin Ds, And Ids-isys 25 Hydroxy Vitamin Ds Control Set.
| Device ID | K140554 |
| 510k Number | K140554 |
| Device Name: | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET |
| Classification | System, Test, Vitamin D |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Contact | Mick Henderson |
| Correspondent | Mick Henderson IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDON 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 | 2014-03-04 |
| Decision Date | 2014-12-19 |
| Summary: | summary |