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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K020769
Device Name SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
Applicant
Lin-Zhi International, Inc.
2391 Zanker Rd., Suite 340
San Jose,  CA  95131 -1124
Applicant Contact CHIU CHIN CHANG
Correspondent
Lin-Zhi International, Inc.
2391 Zanker Rd., Suite 340
San Jose,  CA  95131 -1124
Correspondent Contact CHIU CHIN CHANG
Regulation Number862.3200
Classification Product Code
DLJ  
Subsequent Product Code
LAS  
Date Received03/07/2002
Decision Date 04/03/2002
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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