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FDA 510(k)

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

K-Number: K200256 · 2021-07-02

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2021-07-02
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_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 2021-07-02 under 510(k) number K200256. 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 Ale (Alc_E) Assay?

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200256.

When did ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay receive FDA 510(k) clearance?

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay received FDA 510(k) clearance on 2021-07-02, under 510(k) number K200256.

Who is the listed applicant for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_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 Ale (Alc_E) Assay?

The FDA product code for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay is PDJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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