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FDA 510(k)

Dimension Hemoglobin A1c Assay

K-Number: K173909 · 2018-07-13

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2018-07-13
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Dimension Hemoglobin A1c Assay is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-07-13 under approval number K173909. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dimension Hemoglobin A1c Assay?

Dimension Hemoglobin A1c Assay is a medical device that received FDA 510(k) clearance on 2018-07-13. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K173909.

When was Dimension Hemoglobin A1c Assay approved by the FDA?

Dimension Hemoglobin A1c Assay received FDA 510(k) clearance on 2018-07-13, under approval number K173909.

What company makes Dimension Hemoglobin A1c Assay?

Dimension Hemoglobin A1c Assay is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Dimension Hemoglobin A1c Assay?

The FDA product code for Dimension Hemoglobin A1c Assay is PDJ.

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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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