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FDA 510(k)

ESKAFLOW TEST FOR GLUCOSE

K-Number: K811849 · 1981-07-15

ApplicantSmithkline Diagnostics, Inc.
Decision Date1981-07-15
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESKAFLOW TEST FOR GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-07-15 under 510(k) number K811849. 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 ESKAFLOW TEST FOR GLUCOSE?

ESKAFLOW TEST FOR GLUCOSE is a medical device that received FDA 510(k) clearance on 1981-07-15. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K811849.

When did ESKAFLOW TEST FOR GLUCOSE receive FDA 510(k) clearance?

ESKAFLOW TEST FOR GLUCOSE received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811849.

Who is the listed applicant for ESKAFLOW TEST FOR GLUCOSE?

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

What is the FDA product code for ESKAFLOW TEST FOR GLUCOSE?

The FDA product code for ESKAFLOW TEST FOR GLUCOSE is CFR.

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Related Devices (Code: CFR)

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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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