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FDA 510(k) Application Details - K952515
Device Classification Name
Antithrombin Iii Quantitation
More FDA Info for this Device
510(K) Number
K952515
Device Name
Antithrombin Iii Quantitation
Applicant
CHROMOGENIX AB
160 INDUSTRIAL DR.
FRANKLIN, OH 45005 US
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Contact
CYNTHIA A IPACH
Other 510(k) Applications for this Contact
Regulation Number
864.7060
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Classification Product Code
JBQ
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More FDA Info for this Product Code
Date Received
05/31/1995
Decision Date
01/23/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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