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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 K021449
Device Name CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
Applicant
Lin-Zhi International, Inc.
2391 Zanker Rd. Suite 340
San Jose,  CA  95131
Applicant Contact CHIN CHIN CHANG
Correspondent
Lin-Zhi International, Inc.
2391 Zanker Rd. Suite 340
San Jose,  CA  95131
Correspondent Contact CHIN CHIN CHANG
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received05/06/2002
Decision Date 06/18/2002
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
Recalls CDRH Recalls
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