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FDA 510(k) Application Details - K093001
Device Classification Name
System, Multipurpose For In Vitro Coagulation Studies
More FDA Info for this Device
510(K) Number
K093001
Device Name
System, Multipurpose For In Vitro Coagulation Studies
Applicant
DIAGNOSTICA STAGO, INCORPORATED
5 CENTURY DRIVE
PARSIPPPANY, NJ 07054 US
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Contact
UMBERTO V PARROTTA
Other 510(k) Applications for this Contact
Regulation Number
864.5425
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Classification Product Code
JPA
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More FDA Info for this Product Code
Date Received
09/28/2009
Decision Date
12/18/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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