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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, Opiates
510(k) Number K043507
Device Name ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE
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 Number862.3650
Classification Product Code
DJG  
Date Received12/20/2004
Decision Date 02/25/2005
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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