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FDA 510(k)

Access PCT

K-Number: K222996 · 2023-04-26

ApplicantBeckman Coulter, Inc.
Decision Date2023-04-26
Product CodePTF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Access PCT is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-04-26 under approval number K222996. 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 is a medical device that received FDA 510(k) clearance on 2023-04-26. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K222996.

When was Access PCT approved by the FDA?

Access PCT received FDA 510(k) clearance on 2023-04-26, under approval number K222996.

What company makes Access PCT?

Access PCT is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access PCT?

The FDA product code for Access PCT is PTF.

Other Devices by Beckman Coulter, Inc.

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Related Devices (Code: PTF)

K162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetDiazyme Laboratories K192271Access PCT, Access PCT CalibratorsBeckman 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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