The following data is part of a premarket notification filed by Biotrack, Inc. with the FDA for Biotrack Theophylline Quality Controls.
| Device ID | K903924 |
| 510k Number | K903924 |
| Device Name: | BIOTRACK THEOPHYLLINE QUALITY CONTROLS |
| Classification | Theophylline Control Materials |
| Applicant | BIOTRACK, INC. 1058 HUFF AVE. Mountain View, CA 94043 |
| Contact | Jill Findlay |
| Correspondent | Jill Findlay BIOTRACK, INC. 1058 HUFF AVE. Mountain View, CA 94043 |
| Product Code | LAW |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-24 |
| Decision Date | 1990-09-17 |