The following data is part of a premarket notification filed by Bioresource Technology, Inc. with the FDA for Nod Chemistry Control.
Device ID | K060850 |
510k Number | K060850 |
Device Name: | NOD CHEMISTRY CONTROL |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | BIORESOURCE TECHNOLOGY, INC. 575 Shirlynn Court Los Altos, CA 94022 |
Contact | Erika B Ammirati |
Correspondent | Erika B Ammirati BIORESOURCE TECHNOLOGY, INC. 575 Shirlynn Court Los Altos, CA 94022 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-28 |
Decision Date | 2006-05-30 |