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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
Applicant
Ind Ndiagnostic, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Applicant Contact KAI LOU
Correspondent
Ind Ndiagnostic, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Correspondent 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 (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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