QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS— 510(k) K931756

Name: FDA 510(k) clearance K931756
Creator: U.S. Food and Drug Administration
Published: 1994-04-21

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K931756 for QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS, Substantially Equivalent on 1994-04-21. Applicant: R&D Systems, Inc.. Device class: 2.

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code GGT
Device class: Class 2
Regulation: 21 CFR 864.7250
Advisory panel: Hematology
Date received: 1993-04-08
Decision date: 1994-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGT

view all

K240182 — Access EPO2024-04-22
K183088 — ADVIA Centaur Erythropoietin (EPO) assay2019-08-02
K052223 — ACCESS EPO ASSAY2006-10-06
K992799 — SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT2000-06-07
K983203 — IMMULITE EPO, MODEL #'S LKEPZ & LKEP11999-07-12

More clearances from R&D Systems, Inc.

view all

K160606 — BC-5D Hematology Control2016-09-01
K130962 — R&D 5D RETIC HEMATOLOGY CONTROL2013-07-24
K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL2011-04-28
K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROL2010-01-29
K091433 — R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL2009-10-28

Recalls naming K931756

K-number listed on FDA's recall record

Z-1390-2022 — Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095Class III·Ongoing·R & D Systems, Inc.·20220614

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K931756.

Data sourced from openFDA. This site is unofficial and independent of the FDA.