The following data is part of a premarket notification filed by Biotrack, Inc. with the FDA for Biotrack Therapeutic Drug-monitoring Qual Controls.
| Device ID | K934062 |
| 510k Number | K934062 |
| Device Name: | BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS |
| Classification | Drug Mixture Control Materials |
| Applicant | BIOTRACK, INC. 1058 HUFF AVE. Mountain View, CA 94043 |
| Contact | Bernelle Saperstein |
| Correspondent | Bernelle Saperstein BIOTRACK, INC. 1058 HUFF AVE. Mountain View, CA 94043 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-19 |
| Decision Date | 1993-12-29 |