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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
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