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 |