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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrin Split Products
510(k) Number K920668
Device Name MINUTEX D-DIMER LATEX TEST
Applicant
Biopool AB
1016 Sutton Dr.
Unit C8, Burlington
Ontario, L7l 6b8,  CA L7L 6B8
Applicant Contact ANDREW L CERSKUS
Correspondent
Biopool AB
1016 Sutton Dr.
Unit C8, Burlington
Ontario, L7l 6b8,  CA L7L 6B8
Correspondent Contact ANDREW L CERSKUS
Regulation Number864.7320
Classification Product Code
GHH  
Date Received02/13/1992
Decision Date 10/16/1992
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
Recalls CDRH Recalls
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