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FDA 510(k)

FLOWCARE PLG CD4 REAGENT

K-Number: K043215 · 2005-01-19

ApplicantBeckman Coulter, Inc.
Decision Date2005-01-19
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FLOWCARE PLG CD4 REAGENT 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 2005-01-19 under 510(k) number K043215. 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 FLOWCARE PLG CD4 REAGENT?

FLOWCARE PLG CD4 REAGENT is a medical device that received FDA 510(k) clearance on 2005-01-19. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K043215.

When did FLOWCARE PLG CD4 REAGENT receive FDA 510(k) clearance?

FLOWCARE PLG CD4 REAGENT received FDA 510(k) clearance on 2005-01-19, under 510(k) number K043215.

Who is the listed applicant for FLOWCARE PLG CD4 REAGENT?

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 FLOWCARE PLG CD4 REAGENT?

The FDA product code for FLOWCARE PLG CD4 REAGENT 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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