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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 K954993
Device Name QUIX RAPID PREGNANCY STRIP TEST
Applicant
Guardian Scientific, Corp.
8990-E Rte. 108
Columbia,  MD  21045
Applicant Contact KATHRYN B POWERS
Correspondent
Guardian Scientific, Corp.
8990-E Rte. 108
Columbia,  MD  21045
Correspondent Contact KATHRYN B POWERS
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/31/1995
Decision Date 12/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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