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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 a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-11-24 under approval 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. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K212223.

When was Atellica CH Enzymatic Creatinine_3 (ECre3) approved by the FDA?

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

What company makes Atellica CH Enzymatic Creatinine_3 (ECre3)?

Atellica CH Enzymatic Creatinine_3 (ECre3) is manufactured by Siemens Healthcare Diagnostics, Inc..

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.

Other Devices by Siemens Healthcare Diagnostics, Inc.

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Official Source

View on FDA Database →

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

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