FDA.reportPublic FDA data

510(k) K882686

Device
ERYTHROPOIETIN ENZYME IMMUNOASSAY
Applicant
AMGEN, INC.
510(k) number
K882686
Product code
GGT  
Decision
Substantially Equivalent (SESE)
Decision date
1988-12-20
Date received
1988-06-30
Regulation
864.7250
Classification name
Assay, Erythropoietin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SARAH C SWANSON
Address
1840 De Havilland Thousand Oaks CA US 91320 91320

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