The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Thyroglob.
Device ID | K002888 |
510k Number | K002888 |
Device Name: | NICHOLS ADVANTAGE THYROGLOB |
Classification | System, Test, Thyroglobulin |
Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33047 CALLE AVIADOR San Juan Capistrano, CA 92675 |
Contact | Jimmy Wong |
Correspondent | Jimmy Wong NICHOLS INSTITUTE DIAGNOSTICS 33047 CALLE AVIADOR San Juan Capistrano, CA 92675 |
Product Code | MSW |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-09-15 |
Decision Date | 2000-10-20 |