The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Intact Parathyroid Hormone (pth) Immunoassay (modification).
| Device ID | K954418 |
| 510k Number | K954418 |
| Device Name: | INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Contact | Dave D Smith |
| Correspondent | Dave D Smith NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-22 |
| Decision Date | 1995-11-03 |