The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Octeia 25-hydroxy Vitamin D.
| Device ID | K021163 |
| 510k Number | K021163 |
| Device Name: | OCTEIA 25-HYDROXY VITAMIN D |
| Classification | System, Test, Vitamin D |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS LTD. 10 DIDCOT WAY, BOLDEN BUSINESS PARK Boldon, Tyne & Wear, GB Ne35 9pd |
| Contact | Paul Puntin |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-04-11 |
| Decision Date | 2002-05-10 |