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FDA 510(k)

FLOWCARE TLG REAGENT

K-Number: K081526 · 2008-08-14

ApplicantBeckman Coulter, Inc.
Decision Date2008-08-14
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FLOWCARE TLG 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 2008-08-14 under 510(k) number K081526. 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 TLG REAGENT?

FLOWCARE TLG REAGENT is a medical device that received FDA 510(k) clearance on 2008-08-14. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K081526.

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

FLOWCARE TLG REAGENT received FDA 510(k) clearance on 2008-08-14, under 510(k) number K081526.

Who is the listed applicant for FLOWCARE TLG 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 TLG REAGENT?

The FDA product code for FLOWCARE TLG 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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