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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 K990249
Device Name OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031
Applicant
Phamatech
9265 Activity Rd., #112-113
San Diego,  CA  92126
Applicant Contact CARL MONGIOVI
Correspondent
Phamatech
9265 Activity Rd., #112-113
San Diego,  CA  92126
Correspondent Contact CARL MONGIOVI
Regulation Number862.1485
Classification Product Code
CEP  
Date Received01/26/1999
Decision Date 03/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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