The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd with the FDA for Ids-isys Intact Pthn.
| Device ID | K161158 |
| 510k Number | K161158 |
| Device Name: | IDS-iSYS Intact PTHN |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS LTD 10 DIDCOT WAY BOLDON BUSINESS PARK Boldon, GB Ne35 9pd |
| Contact | Chris Price |
| Correspondent | Mick Henderson IMMUNODIAGNOSTIC SYSTEMS LTD 10 DIDCOT WAY BOLDON BUSINESS PARK Boldon, GB Ne35 9pd |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-25 |
| Decision Date | 2017-01-31 |
| Summary: | summary |