ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay— 510(k) K200256

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K200256 for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay, Substantially Equivalent on 2021-07-02. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code PDJ
Advisory panel: Clinical Chemistry
Date received: 2020-02-03
Decision date: 2021-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.