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FDA 510(k) Application Details - K071255
Device Classification Name
Platelet Factor 4 Radioimmunoassay
More FDA Info for this Device
510(K) Number
K071255
Device Name
Platelet Factor 4 Radioimmunoassay
Applicant
HYPHEN BIOMED
6560 GOVE COURT
MASON, OH 45040 US
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Contact
OLA ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
864.7695
More FDA Info for this Regulation Number
Classification Product Code
LCO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/04/2007
Decision Date
09/07/2007
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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