Name: Predicase
Price: 199 USD

K-number	K162297
Device name	Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
Applicant	Diazyme Laboratories
Product code	PTF
Device class	Class II
Decision date	Apr 18, 2017
Decision	Substantially Equivalent
Regulation	866.3215

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.