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FDA 510(k)

GLUCOLOUR

K-Number: K781308 · 1978-08-31

ApplicantAnalytical & Research Chemicals, Inc.
Decision Date1978-08-31
Product CodeCGE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOLOUR is the device name listed in this FDA 510(k) record. The listed applicant is Analytical & Research Chemicals, Inc.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781308. The device is classified under product code CGE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOLOUR?

GLUCOLOUR is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Analytical & Research Chemicals, Inc.. The 510(k) number is K781308.

When did GLUCOLOUR receive FDA 510(k) clearance?

GLUCOLOUR received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781308.

Who is the listed applicant for GLUCOLOUR?

The FDA 510(k) record lists Analytical & Research Chemicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOLOUR?

The FDA product code for GLUCOLOUR is CGE.

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Other records listing Analytical & Research Chemicals, 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.

K823784ENZYMATIC CHOLESTEROL (COLORIMETRICK823786ALKALINE PHOSPHATASEK823806DIRECT CREATININE PROCEDUREK781441BCG ALBUMIN REAGETK781460CHLORIDE REAGENTK781305UREA NITROGEN

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Related Devices (Code: CGE)

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.

K890335SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.Alpkem Corp.K855185GLUCOSE REAGENT SETTechnostics Intl.K850930GLUCOSEDilab, Inc.K841054DIRECT GLUCOSE REAGENT SETMedical Specialties, Inc.K821198DIRECT GLUCOSE REAGENT SETOmega Medical ElectronicsK811883KING DIAGNOSTICS GLUCOSE-O TESTKing Diagnostics, Inc.

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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