Cleared Traditional

ADVIA Centaur Erythropoietin (EPO) assay

K183088 · Axis-Shield Diagnostics Limited · Hematology
Aug 2019
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K183088 is an FDA 510(k) clearance for the ADVIA Centaur Erythropoietin (EPO) assay, a Assay, Erythropoietin (Class II — Special Controls, product code GGT), submitted by Axis-Shield Diagnostics Limited (Dundee, GB). The FDA issued a Cleared decision on August 2, 2019, 269 days after receiving the submission on November 6, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7250.

Submission Details

510(k) Number K183088 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2018
Decision Date August 02, 2019
Days to Decision 269 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGT — Assay, Erythropoietin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7250

Similar Devices — GGT Assay, Erythropoietin

All 19
Access EPO
K240182 · Beckman Coulter, Inc. · Apr 2024
ACCESS EPO ASSAY
K052223 · Beckman Coulter, Inc. · Oct 2006
SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
K992799 · Sangui Biotech, Inc. · Jun 2000
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
K983203 · Diagnostic Products Corp. · Jul 1999
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
K980737 · Nichols Institute Diagnostics · Mar 1999
ERYTHROPOIETIN IMMUNOASSAY KIT
K952559 · Nichols Institute · May 1996