FDA.reportPublic FDA data

510(k) K912244

Device
UROTEST GPH
Applicant
IN WHA PHARMACEUTICAL CO., LTD.
510(k) number
K912244
Product code
JII  
Decision
Substantially Equivalent (SESE)
Decision date
1991-11-22
Date received
1991-05-21
Regulation
862.3560
Classification name
Atomic Absorption, Lithium
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Address
Buk-Ku Chungchun-Dong 234-1 Korea KR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JII  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K082001DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116BDiazyme Laboratories2008-12-05
K033360DIAZYME LITHIUM ENZYMATIC ASSAY KITGeneral Atomics2003-12-23

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