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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 K934314
Device Name TINTELIZER(R) TPA
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 Number864.7290
Classification Product Code
GGP  
Date Received09/01/1993
Decision Date 02/23/1994
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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