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FDA 510(k) Application Details - K974125
Device Classification Name
Catalytic Methods, Amylase
More FDA Info for this Device
510(K) Number
K974125
Device Name
Catalytic Methods, Amylase
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
862.1070
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Classification Product Code
JFJ
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More FDA Info for this Product Code
Date Received
11/03/1997
Decision Date
12/17/1997
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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