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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 K021409
Device Name AT HOME OVULATION TEST, MODEL 9032
Applicant
Phamatech, Inc.
9530 Padgett St., #101-106
San Diego,  CA  92126
Applicant Contact CARL A MONGIOVI
Correspondent
Phamatech, Inc.
9530 Padgett St., #101-106
San Diego,  CA  92126
Correspondent Contact CARL A MONGIOVI
Regulation Number862.1485
Classification Product Code
CEP  
Date Received05/03/2002
Decision Date 05/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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