FDA.reportPublic FDA data

510(k) K991942

Device
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
Applicant
COGENT DIAGNOTICS LTD.
510(k) number
K991942
Product code
MLE  
Decision
Substantially Equivalent (SESE)
Decision date
1999-08-24
Date received
1999-06-09
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
DANIELLE M KNIGHT
Address
Pentlands Science Park Bush Loan, Penicuik Midlothian, Scotland GB EH26 OPL EH26 OPL

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
K010558QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISAInova Diagnostics, Inc.2001-04-03
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