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FDA 510(k)

Access Intact PTH

K-Number: K232791 · 2024-03-01

ApplicantBeckman Coulter, Inc.
Decision Date2024-03-01
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access Intact PTH is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-03-01 under approval number K232791. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access Intact PTH?

Access Intact PTH is a medical device that received FDA 510(k) clearance on 2024-03-01. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K232791.

When was Access Intact PTH approved by the FDA?

Access Intact PTH received FDA 510(k) clearance on 2024-03-01, under approval number K232791.

What company makes Access Intact PTH?

Access Intact PTH is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access Intact PTH?

The FDA product code for Access Intact PTH is CEW.

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Related Devices (Code: CEW)

K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc. K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd. K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc. K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics K231927Elecsys PTH , Elecsys PTH STATRoche Diagnostics

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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