Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)— 510(k) K233242

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K233242 for Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2), Substantially Equivalent on 2024-01-18. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Code NQD
Device class
Class 2
Regulation
21 CFR 866.5270
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Newark, DE, US
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