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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K923499
Device Name SPECTROLYSE HEPARIN KIT
Applicant
Biopool AB
1016 Sutton Dr.
Unit C8, Burlington
Ontario, L7l 6b8,  CA L7L 6B8
Applicant Contact ANDERW L CERSKUS
Correspondent
Biopool AB
1016 Sutton Dr.
Unit C8, Burlington
Ontario, L7l 6b8,  CA L7L 6B8
Correspondent Contact ANDERW L CERSKUS
Regulation Number864.7525
Classification Product Code
KFF  
Date Received07/15/1992
Decision Date 01/27/1994
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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