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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 K080467
Device Name BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,
Applicant
Applied Dna Technologies, Inc.
26251 Verona Place
Mission Viejo,  CA  92692
Applicant Contact FENG YU-LEE
Correspondent
Applied Dna Technologies, Inc.
26251 Verona Place
Mission Viejo,  CA  92692
Correspondent Contact FENG YU-LEE
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
DKZ   DNK   JXM   LCM   LFG  
Date Received02/21/2008
Decision Date 11/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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