K162297

Substantially Equivalent

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

Applicant: Diazyme Laboratories
Product code: PTF
Advisory panel: Microbiology
Date received: 2016-08-16
Decision date: 2017-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

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