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FDA 510(k)

ADVIA 2120i, ADVIA 2120

K-Number: K162977 · 2017-08-11

ApplicantSiemens Healthcare Diagnostics
Decision Date2017-08-11
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ADVIA 2120i, ADVIA 2120 is a medical device manufactured by Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2017-08-11 under approval number K162977. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA 2120i, ADVIA 2120?

ADVIA 2120i, ADVIA 2120 is a medical device that received FDA 510(k) clearance on 2017-08-11. It is manufactured by Siemens Healthcare Diagnostics. The 510(k) number is K162977.

When was ADVIA 2120i, ADVIA 2120 approved by the FDA?

ADVIA 2120i, ADVIA 2120 received FDA 510(k) clearance on 2017-08-11, under approval number K162977.

What company makes ADVIA 2120i, ADVIA 2120?

ADVIA 2120i, ADVIA 2120 is manufactured by Siemens Healthcare Diagnostics.

What is the FDA product code for ADVIA 2120i, ADVIA 2120?

The FDA product code for ADVIA 2120i, ADVIA 2120 is GKZ.

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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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