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FDA 510(k)

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

K-Number: K171771 · 2017-12-04

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2017-12-04
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-12-04 under approval number K171771. 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 ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay?

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay is a medical device that received FDA 510(k) clearance on 2017-12-04. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K171771.

When was ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay approved by the FDA?

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay received FDA 510(k) clearance on 2017-12-04, under approval number K171771.

What company makes ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay?

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay?

The FDA product code for ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) 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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