4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190— 510(k) K010064

Name: FDA 510(k) clearance K010064
Creator: U.S. Food and Drug Administration
Published: 2001-02-07

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K010064 for 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190, Substantially Equivalent on 2001-02-07. 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: 2001-01-08
Decision date: 2001-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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