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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K110889
Device Name IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
Applicant
Ind Diagnostics, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Applicant Contact KAI LOU
Correspondent
Ind Diagnostics, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Correspondent Contact KAI LOU
Regulation Number862.1155
Classification Product Code
LCX  
Date Received03/30/2011
Decision Date 06/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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