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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 K050878
Device Name ON CALL MULTI-DRUG HOME TEST CUP
Applicant
ACON Laboratories, Inc.
4108 Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact EDWARD TUNG
Correspondent
ACON Laboratories, Inc.
4108 Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact EDWARD TUNG
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DJG   DKZ   LAF   LCM  
Date Received04/06/2005
Decision Date 06/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
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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