FDA 510(k) Premarket Notification K212223: Atellica CH Enzymatic Creatinine_3 (ECre3)

Submission Details & Decision

Normalized public record details for 510(k) notification K212223.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K212223

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

Atellica CH Enzymatic Creatinine_3 (ECre3)

Product Code

JFY

Decision Date

2021-11-24

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

2021-07-16

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