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FDA 510(k) Application Details - K984437
Device Classification Name
Enzyme Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K984437
Device Name
Enzyme Controls (Assayed And Unassayed)
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD, MA 01730 US
Other 510(k) Applications for this Company
Contact
CAROL MARBLE
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJT
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More FDA Info for this Product Code
Date Received
12/14/1998
Decision Date
02/02/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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