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FDA 510(k) Application Details - K980499
Device Classification Name
Antithrombin Iii Quantitation
More FDA Info for this Device
510(K) Number
K980499
Device Name
Antithrombin Iii Quantitation
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON, MA 02173 US
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Contact
CAROL MARBLE
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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
02/09/1998
Decision Date
04/02/1998
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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