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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, follicle-stimulating hormone
510(k) Number K052662
Device Name ONE STEP FSH MENOPAUSAL TEST
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 Number862.1300
Classification Product Code
CGJ  
Date Received09/27/2005
Decision Date 11/30/2005
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
Recalls CDRH Recalls
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