FDA.reportPublic FDA data

510(k) K993850

Device
URINALYSIS REAGENT STRIPS (10 PARAMETERS)
Applicant
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
510(k) number
K993850
Product code
JMT  
Decision
Substantially Equivalent (SESE)
Decision date
2000-01-03
Date received
1999-11-12
Regulation
862.1510
Classification name
Diazo (colorimetric), Nitrite (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
DENNIS S.L. HONG
Address
1629 Fosters Way Delta, B.C. CA V3M 6S7 V3M 6S7

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JMT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251800Healgen® URS Test StripsHealgen Scientific,, LLC2025-12-23
K252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.2025-10-30
K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.2025-01-10
K170118Scanostics UTI Check Application Test SystemTeco Diagnostics2017-09-21
K100024TECO DIAGNOSTICS UTI DETECTION STRIPSTeco Diagnostics2011-02-17
K990873DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USEAmeritek, Inc.1999-09-01
K954685URITEST - NITRITE IN URINE TESTTcpi, Inc.1996-07-22
K960888CHEK-STIX U.T.I. SELF-TESTBayer Corp.1996-07-05
K953672FIRST CHOICE URINARY TRACT INFECTION TEST STRIPSPolymer Technology Intl.1996-07-01
K875248BIOSCAN URINE DIAGNOSTIC REAGENT STRIPSBioscan Instruments, Inc.1988-02-24
K855238BIOTEL (TM)/UTIAmerican Diagnostic Corp.1986-05-09
K840828KYOTEST 8VKyoto Diagnostics, Inc.1984-05-14

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases