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FDA 510(k)

GLUCOSE OXIDASE ENZYMATIC REAGENT SET

K-Number: K843528 · 1984-09-28

ApplicantLivonia Diagnostics, Inc.
Decision Date1984-09-28
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE OXIDASE ENZYMATIC REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Livonia Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-09-28 under 510(k) number K843528. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE OXIDASE ENZYMATIC REAGENT SET?

GLUCOSE OXIDASE ENZYMATIC REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-09-28. The listed applicant is Livonia Diagnostics, Inc.. The 510(k) number is K843528.

When did GLUCOSE OXIDASE ENZYMATIC REAGENT SET receive FDA 510(k) clearance?

GLUCOSE OXIDASE ENZYMATIC REAGENT SET received FDA 510(k) clearance on 1984-09-28, under 510(k) number K843528.

Who is the listed applicant for GLUCOSE OXIDASE ENZYMATIC REAGENT SET?

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

What is the FDA product code for GLUCOSE OXIDASE ENZYMATIC REAGENT SET?

The FDA product code for GLUCOSE OXIDASE ENZYMATIC REAGENT SET is CGA.

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Other records listing Livonia Diagnostics, Inc. as applicant

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Related Devices (Code: CGA)

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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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