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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, luteinizing hormone
510(k) Number K970467
Device Name EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
Applicant
EXCEL SCIENTIFIC, INC.
23071 LA PALMA AVE.
YORBA LINDA,  CA  92887
Applicant Contact MIN-LEE CHENG
Correspondent
EXCEL SCIENTIFIC, INC.
23071 LA PALMA AVE.
YORBA LINDA,  CA  92887
Correspondent Contact MIN-LEE CHENG
Regulation Number862.1485
Classification Product Code
CEP  
Date Received02/07/1997
Decision Date 03/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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