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FDA 510(k)

ITAG MHC TETRAMER CMV ASSAY

K-Number: K051122 · 2005-08-01

ApplicantBeckman Coulter, Inc.
Decision Date2005-08-01
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ITAG MHC TETRAMER CMV ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2005-08-01 under 510(k) number K051122. 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 ITAG MHC TETRAMER CMV ASSAY?

ITAG MHC TETRAMER CMV ASSAY is a medical device that received FDA 510(k) clearance on 2005-08-01. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K051122.

When did ITAG MHC TETRAMER CMV ASSAY receive FDA 510(k) clearance?

ITAG MHC TETRAMER CMV ASSAY received FDA 510(k) clearance on 2005-08-01, under 510(k) number K051122.

Who is the listed applicant for ITAG MHC TETRAMER CMV ASSAY?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ITAG MHC TETRAMER CMV ASSAY?

The FDA product code for ITAG MHC TETRAMER CMV ASSAY 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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