The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Chemiluminescence Free T4- Estimate Kit.
Device ID | K962408 |
510k Number | K962408 |
Device Name: | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT |
Classification | Radioimmunoassay, Free Thyroxine |
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 | CEC |
CFR Regulation Number | 862.1695 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-21 |
Decision Date | 1997-03-18 |