FDA.reportPublic FDA data

510(k) K010558

Device
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
Applicant
INOVA DIAGNOSTICS, INC.
510(k) number
K010558
Product code
MLE  
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-03
Date received
2001-02-26
Regulation
866.5110
Classification name
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRYS C MYERS
Address
10180 Scripps Ranch Blvd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MLE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K991942AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISACogent Diagnotics , Ltd.1999-08-24
K951206VARELISA PARIETAL CELL ANTIBODIESElias U.S.A., Inc.1995-04-17

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