MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

Calibrators, Drug Mixture

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Multiple Analyte Urine Drugs Of Abuse Calibrators And Controls.

Pre-market Notification Details

Device IDK051088
510k NumberK051088
Device Name:MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
ClassificationCalibrators, Drug Mixture
Applicant Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale,  CA  94085 -2917
ContactCheng-i Lin
CorrespondentCheng-i Lin
Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale,  CA  94085 -2917
Product CodeDKB  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-28
Decision Date2005-06-24
Summary:summary

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