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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K052694
Device Name ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
Applicant
Ind Diagnostic, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Applicant Contact JASON PENG
Correspondent
Ind Diagnostic, Inc.
1629 Fosters Way
Delta, B.C.,  CA V3M 6S7
Correspondent Contact JASON PENG
Regulation Number862.1155
Classification Product Code
JHI  
Date Received09/28/2005
Decision Date 12/16/2005
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
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