IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY— 510(k) K101911

Name: FDA 510(k) clearance K101911
Creator: U.S. Food and Drug Administration
Published: 2010-10-18

Substantially Equivalent

Cylex, Inc.

FDA 510(k) clearance K101911 for IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY, Substantially Equivalent on 2010-10-18. Applicant: Cylex, Inc.. Device class: 2.

Clearance details

Applicant: Cylex, Inc.
Product code: Code NID
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2010-07-09
Decision date: 2010-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Baldwin, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NID

view all

K013169 — IMMUNE CELL FUNCTION ASSAY2002-04-02

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