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FDA 510(k)

Access 25(OH) Vitamin D Total

K-Number: K223503 · 2023-01-19

ApplicantBeckman Coulter, Inc.
Decision Date2023-01-19
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access 25(OH) Vitamin D Total 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 2023-01-19 under 510(k) number K223503. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access 25(OH) Vitamin D Total?

Access 25(OH) Vitamin D Total is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K223503.

When did Access 25(OH) Vitamin D Total receive FDA 510(k) clearance?

Access 25(OH) Vitamin D Total received FDA 510(k) clearance on 2023-01-19, under 510(k) number K223503.

Who is the listed applicant for Access 25(OH) Vitamin D Total?

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 25(OH) Vitamin D Total?

The FDA product code for Access 25(OH) Vitamin D Total is MRG.

Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: MRG)

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.

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,K210901Elecsys Vitamin D total IIIRoche DiagnosticsK200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.K180577BioPlex 2200 25-OH Vitamin D KitBio-Rad 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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