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510(k) K911801

Device
KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
Applicant
GDS TECHNOLOGY, LLC.
510(k) number
K911801
Product code
JIN  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-01
Date received
1991-04-23
Regulation
862.1435
Classification name
Nitroprusside, Ketones (urinary, Non-quant.)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DE CASTRO
Address
25235 Leer Dr. P.O. Box 473 Elkhart IN US 46515 46515

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JIN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc.2020-09-09
K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.2020-06-05
K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp.2018-12-18
K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation2018-05-04
K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc.2018-04-13
K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisACON Laboratories, Inc.2017-07-06
K060768PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPSAbbott Diabetes Care, Inc.2006-04-21
K033114KETOCHECKSNeo Diagnostics, Inc.2004-04-26
K003987URS-1K (KETONE TESST)Teco Diagnostics2001-04-26
K953680FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPSPolymer Technology Intl.1996-06-12
K912373KETO-340 IIIhara Medics U.S., Inc.1991-07-01
K910108GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIEDGds Diagnostics1991-03-04
K903365KETOREX SANWA STANDARDSIhara Medics U.S., Inc.1990-12-20
K903366KETONE TEST B SANWA STANDARDIhara Medics U.S., Inc.1990-11-20
K903367KETONE TEST A SANWA STANDARDIhara Medics U.S., Inc.1990-11-20

Legacy Summary#

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FDA Review#

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