FDA.reportPublic FDA data

510(k) K990431

Device
AIA-PACK CA 125
Applicant
TOSOH MEDICS, INC.
510(k) number
K990431
Product code
LTK  
Decision
Substantially Equivalent (SESE)
Decision date
1999-06-03
Date received
1999-02-11
Regulation
866.6010
Classification name
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JUDITH E LOEBEL
Address
347 Oyster Pt. Blvd., Suite 201 South San Francisco CA US 94080 94080

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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