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FDA 510(k)

GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150

K-Number: K000102 · 2000-02-08

ApplicantTeco Diagnostics
Decision Date2000-02-08
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2000-02-08 under 510(k) number K000102. 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) LIQUID REAGENT, MODEL G518-150?

GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 is a medical device that received FDA 510(k) clearance on 2000-02-08. The listed applicant is Teco Diagnostics. The 510(k) number is K000102.

When did GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 receive FDA 510(k) clearance?

GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 received FDA 510(k) clearance on 2000-02-08, under 510(k) number K000102.

Who is the listed applicant for GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150?

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

What is the FDA product code for GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150?

The FDA product code for GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 is CFR.

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Other records listing Teco Diagnostics as applicant

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K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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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.

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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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