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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 K003557
Device Name ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)
Applicant
ACON LABORATORIES, INC.
11175 FLINTKOTE AVE., #F
SAN DIEGO,  CA  92121
Applicant Contact NORA C.R. YORK
Correspondent
ACON LABORATORIES, INC.
11175 FLINTKOTE AVE., #F
SAN DIEGO,  CA  92121
Correspondent Contact NORA C.R. YORK
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received11/17/2000
Decision Date 03/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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