Atellica CH Amylase_2 (AMY_2)— 510(k) K191454

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K191454 for Atellica CH Amylase_2 (AMY_2), Substantially Equivalent on 2019-07-30. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 2019-05-31
Decision date: 2019-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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