K934062 is an FDA 510(k) clearance for the BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 29, 1993, 132 days after receiving the submission on August 19, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K934062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 1993 |
| Decision Date | December 29, 1993 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |