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FDA 510(k) Application Details - K050365
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
More FDA Info for this Device
510(K) Number
K050365
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
HYPHEN BIOMED
6560 GOVE CT.
MASON, OH 45040 US
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Contact
OLA ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
864.7290
More FDA Info for this Regulation Number
Classification Product Code
GGP
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More FDA Info for this Product Code
Date Received
02/14/2005
Decision Date
12/27/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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