COULTER BODY FLUID CONTROL— 510(k) K082162

Name: FDA 510(k) clearance K082162
Creator: U.S. Food and Drug Administration
Published: 2009-02-03

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K082162 for COULTER BODY FLUID CONTROL, Substantially Equivalent on 2009-02-03. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2008-07-31
Decision date: 2009-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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