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FDA 510(k)

DIRECT GLUCOSE REAGENT SET

K-Number: K841054 · 1984-05-01

ApplicantMedical Specialties, Inc.
Decision Date1984-05-01
Product CodeCGE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT GLUCOSE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties, Inc.. It received FDA 510(k) clearance on 1984-05-01 under 510(k) number K841054. 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 DIRECT GLUCOSE REAGENT SET?

DIRECT GLUCOSE REAGENT SET is a medical device that received FDA 510(k) clearance on 1984-05-01. The listed applicant is Medical Specialties, Inc.. The 510(k) number is K841054.

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

DIRECT GLUCOSE REAGENT SET received FDA 510(k) clearance on 1984-05-01, under 510(k) number K841054.

Who is the listed applicant for DIRECT GLUCOSE REAGENT SET?

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

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

The FDA product code for DIRECT GLUCOSE REAGENT SET is CGE.

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Other records listing Medical Specialties, 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.

K946201STAND, INFUSIONK931947CHECKPOINTK926095REFRACTROL-SPK924926MSI-HCTK896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEK883851MSI-CAL 8

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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.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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