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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Cannabinoids
510(k) Number K001567
Device Name ADVANTAGE THC TEST
Applicant
Advantage Diagnostics Corp.
1201 Douglas Ave.
Redwood City,  CA  94063
Applicant Contact JANIS FREESTONE
Correspondent
Advantage Diagnostics Corp.
1201 Douglas Ave.
Redwood City,  CA  94063
Correspondent Contact JANIS FREESTONE
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received05/19/2000
Decision Date 06/19/2000
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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