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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antithrombin Iii Quantitation
510(k) Number K043007
Device Name BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
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 Number864.7060
Classification Product Code
JBQ  
Date Received11/01/2004
Decision Date 11/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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