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FDA 510(k)

ACCESS EPO ASSAY

K-Number: K052223 · 2006-10-06

ApplicantBeckman Coulter, Inc.
Decision Date2006-10-06
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACCESS EPO 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 2006-10-06 under 510(k) number K052223. The device is classified under product code GGT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS EPO ASSAY?

ACCESS EPO ASSAY is a medical device that received FDA 510(k) clearance on 2006-10-06. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K052223.

When did ACCESS EPO ASSAY receive FDA 510(k) clearance?

ACCESS EPO ASSAY received FDA 510(k) clearance on 2006-10-06, under 510(k) number K052223.

Who is the listed applicant for ACCESS EPO 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 ACCESS EPO ASSAY?

The FDA product code for ACCESS EPO ASSAY is GGT.

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Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: GGT)

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.

K240182Access EPOBeckman Coulter, Inc.K183088ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics LimitedK992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITSangui Biotech, Inc.K983203IMMULITE EPO, MODEL #'S LKEPZ & LKEP1Diagnostic Products Corp.K980737ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAYNichols Institute DiagnosticsK952559ERYTHROPOIETIN IMMUNOASSAY KITNichols Institute

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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