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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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-04-26 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K222996.

When did Access PCT receive FDA 510(k) clearance?

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

Who is the listed applicant for Access PCT?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Access PCT?

The FDA product code for Access PCT is PTF.

Other records listing Beckman Coulter, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252169Access BNP IIK254059Access anti-HBc IgMK253687Access anti-HBc TotalK251995Access anti-HAV IgMK250588Access Rubella IgGPMA P980041KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

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Related Devices (Code: PTF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242294DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level ControlsDiasys Diagnostic Systems GmbHK192271Access PCT, Access PCT CalibratorsBeckman Coulter, Inc.K162297Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control SetDiazyme Laboratories

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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