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FDA 510(k) Application Details - K183555
Device Classification Name
Enzymatic Method, Creatinine
More FDA Info for this Device
510(K) Number
K183555
Device Name
Enzymatic Method, Creatinine
Applicant
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford, MA 01730 US
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Contact
Gabriella Erdosy
Other 510(k) Applications for this Contact
Regulation Number
862.1225
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Classification Product Code
JFY
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More FDA Info for this Product Code
Date Received
12/20/2018
Decision Date
02/16/2019
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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