The following data is part of a premarket notification filed by Bioresource Technology, Inc. with the FDA for Nova-one Lipid Control (special Low Interference Liquid Lipid Control).
| Device ID | K040352 |
| 510k Number | K040352 |
| Device Name: | NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIORESOURCE TECHNOLOGY, INC. 1531 N.W. 65TH AVE. Fort Lauderdale, FL 33313 -4542 |
| Contact | Alan Posner |
| Correspondent | Alan Posner BIORESOURCE TECHNOLOGY, INC. 1531 N.W. 65TH AVE. Fort Lauderdale, FL 33313 -4542 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-12 |
| Decision Date | 2004-04-02 |