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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 K030058
Device Name EARLYDETECT MENOPAUSE TEST FOR FSH
Applicant
Early Detect, Inc.
2950 N. Glassell St.
Orange,  CA  92865
Applicant Contact PETER GEORGE
Correspondent
Early Detect, Inc.
2950 N. Glassell St.
Orange,  CA  92865
Correspondent Contact PETER GEORGE
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received01/07/2003
Decision Date 07/30/2003
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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