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FDA 510(k)

GLUCOSE (GDH) REAGENT

K-Number: K791213 · 1979-08-10

ApplicantGilford Diagnostics
Decision Date1979-08-10
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE (GDH) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1979-08-10 under 510(k) number K791213. The device is classified under product code LFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE (GDH) REAGENT?

GLUCOSE (GDH) REAGENT is a medical device that received FDA 510(k) clearance on 1979-08-10. The listed applicant is Gilford Diagnostics. The 510(k) number is K791213.

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

GLUCOSE (GDH) REAGENT received FDA 510(k) clearance on 1979-08-10, under 510(k) number K791213.

Who is the listed applicant for GLUCOSE (GDH) REAGENT?

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

What is the FDA product code for GLUCOSE (GDH) REAGENT?

The FDA product code for GLUCOSE (GDH) REAGENT is LFR.

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Other records listing Gilford Diagnostics 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.

K832094BILIRUBIN CALIBRATORS & CONTROLK831844DIRECT BILIRUBIN REAGENTK831843GILCHEM TOTAL BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORS

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Related Devices (Code: LFR)

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.

K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical CorporationK121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical CorporationK113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation

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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