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FDA 510(k)

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

K-Number: K161494 · 2016-11-15

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2016-11-15
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-11-15 under approval number K161494. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)?

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K161494.

When was Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) approved by the FDA?

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) received FDA 510(k) clearance on 2016-11-15, under approval number K161494.

What company makes Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)?

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)?

The FDA product code for Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) is CGX.

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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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