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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Russel Viper Venom
510(k) Number K932463
Device Name BIOCLOT LA
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 Number864.8950
Classification Product Code
GIR  
Date Received05/21/1993
Decision Date 09/27/1993
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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