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FDA 510(k) Application Details - K981200
Device Classification Name
Test, Qualitative And Quantitative Factor Deficiency
More FDA Info for this Device
510(K) Number
K981200
Device Name
Test, Qualitative And Quantitative Factor Deficiency
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON, MA 02173 US
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Contact
CAROL MARBLE
Other 510(k) Applications for this Contact
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
04/02/1998
Decision Date
05/26/1998
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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