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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, Cannabinoids
510(k) Number K021887
Device Name CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
Applicant
Lin-Zhi International, Inc.
2391 Zanker Rd. Suite 340
San Jose,  CA  95131
Applicant Contact CHIU CHIN CHANG
Correspondent
Lin-Zhi International, Inc.
2391 Zanker Rd. Suite 340
San Jose,  CA  95131
Correspondent Contact CHIU CHIN CHANG
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received06/07/2002
Decision Date 08/15/2002
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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