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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 K881806
Device Name QLT ABSOLUTE URINE-HCG PREGNANCY TEST
Applicant
Quadra Logic Technologies, Inc.
5th Floor - 520 W. 6th Ave.
Vancouver, British Columbia
Canada,  CA V5Z 4H5
Applicant Contact KING F HUI
Correspondent
Quadra Logic Technologies, Inc.
5th Floor - 520 W. 6th Ave.
Vancouver, British Columbia
Canada,  CA V5Z 4H5
Correspondent Contact KING F HUI
Regulation Number862.1155
Classification Product Code
JHI  
Date Received04/28/1988
Decision Date 08/02/1988
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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