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FDA 510(k)

GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED

K-Number: K910108 · 1991-03-04

ApplicantGds Diagnostics
Decision Date1991-03-04
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Gds Diagnostics. It received FDA 510(k) clearance on 1991-03-04 under 510(k) number K910108. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED?

GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED is a medical device that received FDA 510(k) clearance on 1991-03-04. The listed applicant is Gds Diagnostics. The 510(k) number is K910108.

When did GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED receive FDA 510(k) clearance?

GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED received FDA 510(k) clearance on 1991-03-04, under 510(k) number K910108.

Who is the listed applicant for GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED?

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

What is the FDA product code for GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED?

The FDA product code for GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED is JIN.

Related Clinical Trials

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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Other records listing Gds 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.

K931257ACETASITEK910881CONTROL AND LINEARITYK891761GDS ENZYMATIC THEOPHYLLINE REAGENT

Related Devices (Code: JIN)

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.

K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc.K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp.K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology CorporationK170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc.K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisACON Laboratories, Inc.

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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