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FDA 510(k)

ACR ENZYMATIC GLUCOSE OXIDASE

K-Number: K812258 · 1981-08-31

ApplicantHarleco
Decision Date1981-08-31
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACR ENZYMATIC GLUCOSE OXIDASE is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-08-31 under 510(k) number K812258. 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 ACR ENZYMATIC GLUCOSE OXIDASE?

ACR ENZYMATIC GLUCOSE OXIDASE is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is Harleco. The 510(k) number is K812258.

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

ACR ENZYMATIC GLUCOSE OXIDASE received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812258.

Who is the listed applicant for ACR ENZYMATIC GLUCOSE OXIDASE?

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

What is the FDA product code for ACR ENZYMATIC GLUCOSE OXIDASE?

The FDA product code for ACR ENZYMATIC GLUCOSE OXIDASE is 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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