FDA 510(k)

Atellica CH Enzymatic Creatinine_3 (ECre3)

K-Number: K212223 · 2021-11-24

ApplicantSiemens Healthcare Diagnostics, Inc.

Decision Date2021-11-24

Product CodeJFY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Atellica CH Enzymatic Creatinine_3 (ECre3) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-11-24 under 510(k) number K212223. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atellica CH Enzymatic Creatinine_3 (ECre3)?

Atellica CH Enzymatic Creatinine_3 (ECre3) is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K212223.

When did Atellica CH Enzymatic Creatinine_3 (ECre3) receive FDA 510(k) clearance?

Atellica CH Enzymatic Creatinine_3 (ECre3) received FDA 510(k) clearance on 2021-11-24, under 510(k) number K212223.

Who is the listed applicant for Atellica CH Enzymatic Creatinine_3 (ECre3)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atellica CH Enzymatic Creatinine_3 (ECre3)?

The FDA product code for Atellica CH Enzymatic Creatinine_3 (ECre3) is JFY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.