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FDA 510(k)

GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)

K-Number: K031135 · 2003-06-02

ApplicantDade Behring, Inc.
Decision Date2003-06-02
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2003-06-02 under 510(k) number K031135. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)?

GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) is a medical device that received FDA 510(k) clearance on 2003-06-02. The listed applicant is Dade Behring, Inc.. The 510(k) number is K031135.

When did GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) receive FDA 510(k) clearance?

GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) received FDA 510(k) clearance on 2003-06-02, under 510(k) number K031135.

Who is the listed applicant for GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)?

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

What is the FDA product code for GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)?

The FDA product code for GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) is CFR.

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Related Devices (Code: CFR)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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