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FDA 510(k) Application Details - K130090
Device Classification Name
System, Multipurpose For In Vitro Coagulation Studies
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510(K) Number
K130090
Device Name
System, Multipurpose For In Vitro Coagulation Studies
Applicant
DIAGNOSTICA STAGO, INCORPORATED
PIAZZA ALBANIA, 10
ROME 00153 IT
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Contact
CARLO D'ALESSANDRO
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
01/14/2013
Decision Date
02/12/2013
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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