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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 K910351
Device Name MINICLINIC OVULATION PREDICTION TEST
Applicant
Vanguard Biomedical Corp.
7822 Convoy Ct.
San Diego,  CA  92111
Applicant Contact JOHN CHIU
Correspondent
Vanguard Biomedical Corp.
7822 Convoy Ct.
San Diego,  CA  92111
Correspondent Contact JOHN CHIU
Regulation Number862.1485
Classification Product Code
CEP  
Date Received01/15/1991
Decision Date 03/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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