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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Barbiturate
510(k) Number K030211
Device Name RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
Applicant
Icn Biomedicals, Inc.
1429 Rollins Rd.
Burlingame,  CA  94010
Applicant Contact CHARKES C.F. YU
Correspondent
Icn Biomedicals, Inc.
1429 Rollins Rd.
Burlingame,  CA  94010
Correspondent Contact CHARKES C.F. YU
Regulation Number862.3150
Classification Product Code
DKX  
Date Received01/21/2003
Decision Date 06/13/2003
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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