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FDA 510(k)

GLUCOSE HEXOKINASE COIL REAGENT SYSTEM

K-Number: K791760 · 1979-09-27

ApplicantFisher Scientific Co., LLC
Decision Date1979-09-27
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE HEXOKINASE COIL REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1979-09-27 under 510(k) number K791760. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE HEXOKINASE COIL REAGENT SYSTEM?

GLUCOSE HEXOKINASE COIL REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1979-09-27. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K791760.

When did GLUCOSE HEXOKINASE COIL REAGENT SYSTEM receive FDA 510(k) clearance?

GLUCOSE HEXOKINASE COIL REAGENT SYSTEM received FDA 510(k) clearance on 1979-09-27, under 510(k) number K791760.

Who is the listed applicant for GLUCOSE HEXOKINASE COIL REAGENT SYSTEM?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE HEXOKINASE COIL REAGENT SYSTEM?

The FDA product code for GLUCOSE HEXOKINASE COIL REAGENT SYSTEM is CFR.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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Related Devices (Code: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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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