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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 K050367
Device Name BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
Applicant
Hyphen Biomed
6560 Gove Ct.
Mason,  OH  45040
Applicant Contact OLA ANDERSON
Correspondent
Hyphen Biomed
6560 Gove Ct.
Mason,  OH  45040
Correspondent Contact OLA ANDERSON
Regulation Number864.7525
Classification Product Code
KFF  
Date Received02/14/2005
Decision Date 05/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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