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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 K050741
Device Name IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
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 Received03/21/2005
Decision Date 05/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
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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