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FDA 510(k) Application Details - K182063
Device Classification Name
Enzymatic Method, Creatinine
More FDA Info for this Device
510(K) Number
K182063
Device Name
Enzymatic Method, Creatinine
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626 US
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Contact
Marlene Hanna
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
08/01/2018
Decision Date
10/30/2018
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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