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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K964574
Device Name AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
Applicant
Athena Medical Corp.
10180 SW Nimbus Ave.
Suite J-5
Portland,  OR  97223 -4340
Applicant Contact PATRICIA FEETHAM
Correspondent
Athena Medical Corp.
10180 SW Nimbus Ave.
Suite J-5
Portland,  OR  97223 -4340
Correspondent Contact PATRICIA FEETHAM
Regulation Number862.1155
Classification Product Code
JHI  
Date Received11/14/1996
Decision Date 01/21/1997
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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