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FDA 510(k)

Diazyme EZ Vitamin D Assay

K-Number: K172992 · 2018-01-11

ApplicantDiazyme Laboratories
Decision Date2018-01-11
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Diazyme EZ Vitamin D Assay is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K172992. 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 Diazyme EZ Vitamin D Assay?

Diazyme EZ Vitamin D Assay is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Diazyme Laboratories. The 510(k) number is K172992.

When did Diazyme EZ Vitamin D Assay receive FDA 510(k) clearance?

Diazyme EZ Vitamin D Assay received FDA 510(k) clearance on 2018-01-11, under 510(k) number K172992.

Who is the listed applicant for Diazyme EZ Vitamin D Assay?

The FDA 510(k) record lists Diazyme Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diazyme EZ Vitamin D Assay?

The FDA product code for Diazyme EZ Vitamin D Assay is MRG.

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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.,K223503Access 25(OH) Vitamin D TotalBeckman Coulter, 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.

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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