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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 K050365
Device Name BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
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 Number864.7290
Classification Product Code
GGP  
Date Received02/14/2005
Decision Date 12/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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