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FDA 510(k) Application Details - K082248
Device Classification Name
System, Multipurpose For In Vitro Coagulation Studies
More FDA Info for this Device
510(K) Number
K082248
Device Name
System, Multipurpose For In Vitro Coagulation Studies
Applicant
DIAGNOSTICA STAGO, INC.
5 CENTURY DR.
PARSIPPANY, 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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/08/2008
Decision Date
12/12/2008
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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