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FDA 510(k) Application Details - K062430
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
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510(K) Number
K062430
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD, MA 01730 US
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Contact
CAROL MARBLE
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Regulation Number
864.7290
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Classification Product Code
GGP
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More FDA Info for this Product Code
Date Received
08/21/2006
Decision Date
09/01/2006
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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