The following data is part of a premarket notification filed by Biotrack, Inc. with the FDA for Biotrack Phenytoin Test Cartridge.
| Device ID | K915755 |
| 510k Number | K915755 |
| Device Name: | BIOTRACK PHENYTOIN TEST CARTRIDGE |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| 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 | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-23 |
| Decision Date | 1992-07-23 |