Atellica® CH Diazo Direct Bilirubin (D_DBil)— 510(k) K223078

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K223078 for Atellica® CH Diazo Direct Bilirubin (D_DBil), Substantially Equivalent on 2023-06-12. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 2022-09-30
Decision date: 2023-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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