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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name saline, vascular access flush
510(k) Number K121231
Device Name IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
Original Applicant
IND NDIAGNOSTIC INC.
1629 fosters way
delta, british columbia,  CA v3m 6s7
Original Contact kai lou
Regulation Number880.5200
Classification Product Code
NGT  
Subsequent Product Codes
NFW   NFY   NGG   NGI  
Date Received04/24/2012
Decision Date 07/30/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee General Hospital
Review Advisory Committee Toxicology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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