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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 K983113
Device Name BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
Applicant
SYNTRON BIORESEARCH, INC.
2774 LOKER AVE. WEST
CARLSBAD,  CA  92008
Applicant Contact CHARLES YU
Correspondent
SYNTRON BIORESEARCH, INC.
2774 LOKER AVE. WEST
CARLSBAD,  CA  92008
Correspondent Contact CHARLES YU
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/04/1998
Decision Date 11/18/1998
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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