The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd with the FDA for Ids-isys 25vitds, Ids-isys 25vitds Control Set.
| Device ID | K161831 |
| 510k Number | K161831 |
| Device Name: | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set |
| Classification | System, Test, Vitamin D |
| Applicant | Immunodiagnostic Systems Ltd 10 Didcot Way, Boldon Business Park Boldon, GB Ne35 9pd |
| Contact | Mick Henderson |
| Correspondent | Mick Henderson Immunodiagnostic Systems Ltd 10 Didcot Way, Boldon Business Park Boldon, 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 | 2016-07-05 |
| Decision Date | 2016-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060169695306 | K161831 | 000 |