The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Ids-isys Intact Pth.
| Device ID | K103325 |
| 510k Number | K103325 |
| Device Name: | IDS-ISYS INTACT PTH |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| 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 | CEW |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-12 |
| Decision Date | 2012-02-03 |