The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for C-terminal/mid-molecule Parathyroid -.
Device ID | K843685 |
510k Number | K843685 |
Device Name: | C-TERMINAL/MID-MOLECULE PARATHYROID - |
Classification | Radioimmunoassay, Parathyroid Hormone |
Applicant | NICHOLS INSTITUTE DIAGNOSTICS P.O. BOX 92797 Los Angeles, CA 90009 |
Contact | Elaine Walton |
Correspondent | Elaine Walton NICHOLS INSTITUTE DIAGNOSTICS P.O. BOX 92797 Los Angeles, CA 90009 |
Product Code | CEW |
CFR Regulation Number | 862.1545 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-18 |
Decision Date | 1984-10-11 |