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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, Barbiturate
510(k) Number K023946
Device Name ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN 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 Number862.3150
Classification Product Code
DIS  
Subsequent Product Codes
DJC   DJG   DJR   JXM   LFG  
Date Received11/27/2002
Decision Date 02/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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