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FDA 510(k)

Access PCT, Access PCT Calibrators

K-Number: K192271 · 2019-11-26

ApplicantBeckman Coulter, Inc.
Decision Date2019-11-26
Product CodePTF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Access PCT, Access PCT Calibrators is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2019-11-26 under approval number K192271. 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 Access PCT, Access PCT Calibrators?

Access PCT, Access PCT Calibrators is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K192271.

When was Access PCT, Access PCT Calibrators approved by the FDA?

Access PCT, Access PCT Calibrators received FDA 510(k) clearance on 2019-11-26, under approval number K192271.

What company makes Access PCT, Access PCT Calibrators?

Access PCT, Access PCT Calibrators is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access PCT, Access PCT Calibrators?

The FDA product code for Access PCT, Access PCT Calibrators is PTF.

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Related Devices (Code: PTF)

K162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetDiazyme Laboratories 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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