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FDA 510(k)

GLUCOSE (HK) REAGENT, UNIVERSAL

K-Number: K905227 · 1991-03-11

ApplicantEnzyme Technology, Inc.
Decision Date1991-03-11
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE (HK) REAGENT, UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Enzyme Technology, Inc.. It received FDA 510(k) clearance on 1991-03-11 under 510(k) number K905227. 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 (HK) REAGENT, UNIVERSAL?

GLUCOSE (HK) REAGENT, UNIVERSAL is a medical device that received FDA 510(k) clearance on 1991-03-11. The listed applicant is Enzyme Technology, Inc.. The 510(k) number is K905227.

When did GLUCOSE (HK) REAGENT, UNIVERSAL receive FDA 510(k) clearance?

GLUCOSE (HK) REAGENT, UNIVERSAL received FDA 510(k) clearance on 1991-03-11, under 510(k) number K905227.

Who is the listed applicant for GLUCOSE (HK) REAGENT, UNIVERSAL?

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

What is the FDA product code for GLUCOSE (HK) REAGENT, UNIVERSAL?

The FDA product code for GLUCOSE (HK) REAGENT, UNIVERSAL is CFR.

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Other records listing Enzyme Technology, 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.

K912027CALCIUM (ARSENAZO III) REAGENT, UNIVERSALK912028URIC ACID (URICASE) REAGENT, UNIVERSALK905226TRIGLYCERIDE (GPO) REAGENT, UNIVERSALK896073CHOLESTEROL, UNIVERSAL ET

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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