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FDA 510(k)

GLUCOSE OXIDASE REAGENT SET

K-Number: K791669 · 1979-09-24

ApplicantMacomb Chemical Co.
Decision Date1979-09-24
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE OXIDASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Macomb Chemical Co.. It received FDA 510(k) clearance on 1979-09-24 under 510(k) number K791669. 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 REAGENT SET?

GLUCOSE OXIDASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1979-09-24. The listed applicant is Macomb Chemical Co.. The 510(k) number is K791669.

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

GLUCOSE OXIDASE REAGENT SET received FDA 510(k) clearance on 1979-09-24, under 510(k) number K791669.

Who is the listed applicant for GLUCOSE OXIDASE REAGENT SET?

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

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

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

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Other records listing Macomb Chemical Co. 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.

K830095RAPID CHEM ANALYZER IIK823720SPECTROPHOTOMETERK810958GLYCOHEMOGLOBINK801086P-NITROPHENYL PHOSPHATEK800719ENZYMATIC UREA NITROGEN REAGENT SET REVIK800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO

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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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