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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name assay to measure pct to aid in the risk assessment of critically ill patients on their first day of icu admission
510(k) Number K162297
Device Name Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
Diazyme Laboratories
12889 Gregg Court
Poway,  CA  92130
Applicant Contact Abhijit Datta
Diazyme Laboratories
12889 Gregg Court
Poway,  CA  92130
Correspondent Contact Abhijit Datta
Regulation Number866.3215
Classification Product Code
Date Received08/16/2016
Decision Date 04/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No