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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 the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-12-04 under 510(k) 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. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K171771.

When did ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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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.

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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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