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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, opiates
510(k) Number K081008
Device Name BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
Applicant
Lin-Zhi International, Inc.
687 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2917
Applicant Contact MARIE LIN
Correspondent
Lin-Zhi International, Inc.
687 NORTH PASTORIA AVE.
SUNNYVALE,  CA  94085 -2917
Correspondent Contact MARIE LIN
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DLJ   LAS  
Date Received04/10/2008
Decision Date 12/22/2008
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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