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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, Amphetamine
510(k) Number K973726
Device Name FINGERPRINT DRUG SCREENING DEVICE
Applicant
Applied Technology Ventures, LLC
2190 Fox Mill Rd., Suite 200
Herndon,  VA  20171
Applicant Contact RICHARD ROBLIN
Correspondent
Applied Technology Ventures, LLC
2190 Fox Mill Rd., Suite 200
Herndon,  VA  20171
Correspondent Contact RICHARD ROBLIN
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJG   LCM   LDJ  
Date Received09/30/1997
Decision Date 11/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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