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FDA 510(k)

GLUCOSE OXIDASE RATE REAGENT

K-Number: K811165 · 1981-08-13

ApplicantChem-Elec, Inc.
Decision Date1981-08-13
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE OXIDASE RATE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Chem-Elec, Inc.. It received FDA 510(k) clearance on 1981-08-13 under 510(k) number K811165. 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 RATE REAGENT?

GLUCOSE OXIDASE RATE REAGENT is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is Chem-Elec, Inc.. The 510(k) number is K811165.

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

GLUCOSE OXIDASE RATE REAGENT received FDA 510(k) clearance on 1981-08-13, under 510(k) number K811165.

Who is the listed applicant for GLUCOSE OXIDASE RATE REAGENT?

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

What is the FDA product code for GLUCOSE OXIDASE RATE REAGENT?

The FDA product code for GLUCOSE OXIDASE RATE REAGENT is CGA.

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Other records listing Chem-Elec, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K943503CHEMCARD GLUCOSE TESTK864159SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOODK811406CREATININE RATE REAGENT KITK811319CHLORIDE REAGENT KITK811381ASTRAK811310SODIUM/POTASSIUM REAGENT KITS

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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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