BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS— 510(k) K934062

Substantially Equivalent

Biotrack, Inc.

FDA 510(k) clearance K934062 for BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS, Substantially Equivalent on 1993-12-29. Applicant: Biotrack, Inc.. Device class: 1.

Clearance details

Applicant
Biotrack, Inc.
Product code
Code DIF
Device class
Class 1
Regulation
21 CFR 862.3280
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mountain View, CA, US
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