Home / Device Classification / GGT

GGT — Assay, Erythropoietin Class II

FDA Device Classification

Classification Details

Product Code
GGT
Device Class
Class II
Regulation Number
864.7250
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240182beckman coulterAccess EPOApril 22, 2024
K183088axis-shield diagnostics limitedADVIA Centaur Erythropoietin (EPO) assayAugust 2, 2019
K052223beckman coulterACCESS EPO ASSAYOctober 6, 2006
K992799sangui biotechSANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITJune 7, 2000
K983203diagnostic productsIMMULITE EPO, MODEL #'S LKEPZ & LKEP1July 12, 1999
K980737nichols institute diagnosticsADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAYMarch 23, 1999
K952559nichols instituteERYTHROPOIETIN IMMUNOASSAY KITMay 29, 1996
K954898genzymePREDICTA ERYTHROPOIETIN KIT (MODIFICATION)February 5, 1996
K936016r and d systemsQUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)July 19, 1994
K931756r and d systemsQUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLSApril 21, 1994
K932650nichols instituteERYTHROPOIETIN IMMUNOASSAY KITMarch 11, 1994
K931666r and d systemsQUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAYJuly 20, 1993
K926390genzymePREDICTA ERYTHROPOIETIN KITJune 25, 1993
K910481ramco laboratoriesEPO-RIANovember 29, 1991
K903492diagnostic systems laboratoriesDSL ERYTHROPOIETIN (DSL # 1100)October 26, 1990
K902639incstarEPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)August 22, 1990
K893393incstarEPO-TRAC BY RADIOIMMUNOASSAY (RIA)November 21, 1989
K894943amgenCLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3October 10, 1989
K882686amgenERYTHROPOIETIN ENZYME IMMUNOASSAYDecember 20, 1988
K833957jcl clinical researchERYTHROPOIETIN EIAMarch 23, 1984