510(k) K052719

Device: URITEST 10 URINALYSIS REAGENT STRIPS
Applicant: ARJ MEDICAL, INC.
510(k) number: K052719
Product code: CDM
Decision: Substantially Equivalent (SESE)
Decision date: 2006-12-05
Date received: 2005-09-29
Regulation: 862.1785
Classification name: Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.)
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10763924710147	Accutest	JANT PHARMACAL CORPORATION	2016-09-24
10763924410146	Accutest	JANT PHARMACAL CORPORATION	2016-09-24
10763924210142	Accutest	JANT PHARMACAL CORPORATION	2016-09-24

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K061559	ACON URINALYSIS REAGENT STRIPS	Acon Laboratories Co.	2006-08-11
K880584	URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C	Mach Diag. C/O Wichita State University	1988-05-31
K873366	WAKO(TM) PRETEST 5A	Wako Chemicals USA, Inc.	1988-01-21
K852611	TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE	Miles Laboratories, Inc.	1985-09-03
K821799	FITKIT I CHECKUP KIT	Patton, Boggs & Blow	1983-08-16
K830340	FITKIT I CHECKUP KIT	Boditestor	1983-08-16
K831623	DIA STRIPS SYSTEM	California Immuno Diagnostic, Inc.	1983-07-28
K790965	REAGENT STRIPS FOR URINALYSIS	Miles Laboratories, Inc.	1979-06-28

summary

Decision Summary