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 |