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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 -1124
Applicant Contact CHIN CHIN CHANG
Correspondent
Lin-Zhi International, Inc.
2391 ZANKER RD., SUITE 340
SAN JOSE,  CA  95131 -1124
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
Recalls CDRH Recalls
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