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FDA 510(k)

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

K-Number: K162297 · 2017-04-18

ApplicantDiazyme Laboratories
Decision Date2017-04-18
Product CodePTF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set is a medical device manufactured by Diazyme Laboratories. It received FDA 510(k) clearance on 2017-04-18 under approval number K162297. The device is classified under product code PTF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set?

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set is a medical device that received FDA 510(k) clearance on 2017-04-18. It is manufactured by Diazyme Laboratories. The 510(k) number is K162297.

When was Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set approved by the FDA?

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set received FDA 510(k) clearance on 2017-04-18, under approval number K162297.

What company makes Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set?

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set is manufactured by Diazyme Laboratories.

What is the FDA product code for Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set?

The FDA product code for Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set is PTF.

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Related Devices (Code: PTF)

K192271Access PCT, Access PCT CalibratorsBeckman Coulter, Inc. K222996Access PCTBeckman Coulter, Inc. K242294DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level ControlsDiasys Diagnostic Systems GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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