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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
510(k) Number K002642
Device Name MINIQUANT D-DIMER, MODEL 1447
Applicant
BIOPOOL INTL., INC.
6025 NICOLLE ST.
VENTURA,  CA  93003
Applicant Contact MICHAEL D BICK
Correspondent
BIOPOOL INTL., INC.
6025 NICOLLE ST.
VENTURA,  CA  93003
Correspondent Contact MICHAEL D BICK
Regulation Number864.7320
Classification Product Code
DAP  
Date Received08/24/2000
Decision Date 02/05/2001
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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