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FDA 510(k)

KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON

K-Number: K911801 · 1991-07-01

ApplicantGds Technology, LLC
Decision Date1991-07-01
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON is the device name listed in this FDA 510(k) record. The listed applicant is Gds Technology, LLC. It received FDA 510(k) clearance on 1991-07-01 under 510(k) number K911801. 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 KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON?

KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON is a medical device that received FDA 510(k) clearance on 1991-07-01. The listed applicant is Gds Technology, LLC. The 510(k) number is K911801.

When did KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON receive FDA 510(k) clearance?

KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON received FDA 510(k) clearance on 1991-07-01, under 510(k) number K911801.

Who is the listed applicant for KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON?

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

What is the FDA product code for KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON?

The FDA product code for KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON is JIN.

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Other records listing Gds Technology, 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.

K994073HEMOSITE TEST SYSTEMK992132CHOLESITE TEST SYSTEMK973649HEMOSITE TEST SYSTEMK971145GLUCOSITE TEST SYSTEMK882038GDS ENZYMATIC SALICYLATE REAGENTK880829GDS ENZYMATIC ACETAMINOPHEN REAGENT

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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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