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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K973570
Device Name QUICK CARD HCG ONE STEP PREGNANCY TEST
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 Number862.1155
Classification Product Code
LCX  
Date Received09/19/1997
Decision Date 10/31/1997
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
Predetermined Change
Control Plan Authorized		 No
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