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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, barbiturate
510(k) Number K032764
Device Name BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
Applicant
Lin-Zhi International, Inc.
687 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2917
Applicant Contact CHENG-I LIN
Correspondent
Lin-Zhi International, Inc.
687 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2917
Correspondent Contact CHENG-I LIN
Regulation Number862.3150
Classification Product Code
DIS  
Subsequent Product Codes
DLJ   LAS  
Date Received09/05/2003
Decision Date 11/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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