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FDA 510(k)

GLUCOSE

K-Number: K850930 · 1985-06-10

ApplicantDilab, Inc.
Decision Date1985-06-10
Product CodeCGE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Dilab, Inc.. It received FDA 510(k) clearance on 1985-06-10 under 510(k) number K850930. 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 GLUCOSE?

GLUCOSE is a medical device that received FDA 510(k) clearance on 1985-06-10. The listed applicant is Dilab, Inc.. The 510(k) number is K850930.

When did GLUCOSE receive FDA 510(k) clearance?

GLUCOSE received FDA 510(k) clearance on 1985-06-10, under 510(k) number K850930.

Who is the listed applicant for GLUCOSE?

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

What is the FDA product code for GLUCOSE?

The FDA product code for GLUCOSE is CGE.

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Related PubMed Literature

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.

PMID: 41693672Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report.Journal of diabetes science and technology ()PMID: 37272495An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection.Journal of diabetes science and technology ()

Other records listing Dilab, 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.

K862530RAPID AS LATEXK850931ALBUMINK850938CHOLESTEROLK850934PHOSPHORUSK850933URIC ACIDK850936TOTAL PROTEINS

View all 11 devices →

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.K841054DIRECT GLUCOSE REAGENT SETMedical Specialties, Inc.K821198DIRECT GLUCOSE REAGENT SETOmega Medical ElectronicsK811883KING DIAGNOSTICS GLUCOSE-O TESTKing Diagnostics, Inc.K8100896% ORTHO LOLIUDINE REAGENT IN GLACID ACIAnco Medical Reagents & Assoc.

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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