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FDA 510(k)

ADVIA 2120/2120I BODY FLUIDS

K-Number: K090346 · 2010-07-28

ApplicantSiemens Healthcare Diagnostics
Decision Date2010-07-28
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ADVIA 2120/2120I BODY FLUIDS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2010-07-28 under 510(k) number K090346. 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 2120/2120I BODY FLUIDS?

ADVIA 2120/2120I BODY FLUIDS is a medical device that received FDA 510(k) clearance on 2010-07-28. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K090346.

When did ADVIA 2120/2120I BODY FLUIDS receive FDA 510(k) clearance?

ADVIA 2120/2120I BODY FLUIDS received FDA 510(k) clearance on 2010-07-28, under 510(k) number K090346.

Who is the listed applicant for ADVIA 2120/2120I BODY FLUIDS?

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

What is the FDA product code for ADVIA 2120/2120I BODY FLUIDS?

The FDA product code for ADVIA 2120/2120I BODY FLUIDS is GKZ.

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Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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