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FDA 510(k)

ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I

K-Number: K102644 · 2011-11-23

ApplicantSiemens Healthcare Diagnostics
Decision Date2011-11-23
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I 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 2011-11-23 under 510(k) number K102644. 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 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I?

ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K102644.

When did ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I receive FDA 510(k) clearance?

ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I received FDA 510(k) clearance on 2011-11-23, under 510(k) number K102644.

Who is the listed applicant for ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I?

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 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I?

The FDA product code for ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I is GKZ.

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Related Devices (Code: 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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