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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K934062
Device Name BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS
Applicant
Biotrack, Inc.
1058 Huff Ave.
Mountain View,  CA  94043
Applicant Contact BERNELLE SAPERSTEIN
Correspondent
Biotrack, Inc.
1058 Huff Ave.
Mountain View,  CA  94043
Correspondent Contact BERNELLE SAPERSTEIN
Regulation Number862.3280
Classification Product Code
DIF  
Date Received08/19/1993
Decision Date 12/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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