The following data is part of a premarket notification filed by I.d.s. with the FDA for Octeia Intact Pth.
| Device ID | K941878 |
| 510k Number | K941878 |
| Device Name: | OCTEIA INTACT PTH |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | I.D.S. BOLDON BUSINESS PARK Tyne & Wear, GB Ne35 9pd |
| Contact | Anita Groundwater |
| Correspondent | Anita Groundwater I.D.S. BOLDON BUSINESS PARK Tyne & Wear, 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 | 1994-04-18 |
| Decision Date | 1994-09-07 |