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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 Mixture
510(k) Number K051088
Device Name MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
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 Number862.3200
Classification Product Code
DKB  
Subsequent Product Code
DIF  
Date Received04/28/2005
Decision Date 06/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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