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FDA 510(k) Application Details - K133005
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
More FDA Info for this Device
510(K) Number
K133005
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD, MA 01730 US
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Contact
Jacqueline Emery
Other 510(k) Applications for this Contact
Regulation Number
864.7290
More FDA Info for this Regulation Number
Classification Product Code
GGP
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More FDA Info for this Product Code
Date Received
09/25/2013
Decision Date
03/13/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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