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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K915163
Device Name PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES
Applicant
BIOPOOL AB
430 YORK BLVD., HAMILTON
ONTARIO L8R 3K8,  CA
Applicant Contact ANDREW L CERSKUS
Correspondent
BIOPOOL AB
430 YORK BLVD., HAMILTON
ONTARIO L8R 3K8,  CA
Correspondent Contact ANDREW L CERSKUS
Regulation Number864.7290
Classification Product Code
GGP  
Date Received11/14/1991
Decision Date 01/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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