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FDA 510(k) Application Details - K032951
Device Classification Name
System, Automated Platelet Aggregation
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510(K) Number
K032951
Device Name
System, Automated Platelet Aggregation
Applicant
CHRONO-LOG CORP.
2 WEST PARK RD.
HAVERTOWN, PA 19083 US
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Contact
NICHOLAS J VERIABO
Other 510(k) Applications for this Contact
Regulation Number
864.5700
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Classification Product Code
JOZ
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More FDA Info for this Product Code
Date Received
09/22/2003
Decision Date
04/02/2004
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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