COULTER LIN-X LINEARITY CONTROL, MODEL A81196— 510(k) K100790

Name: FDA 510(k) clearance K100790
Creator: U.S. Food and Drug Administration
Published: 2010-12-21

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K100790 for COULTER LIN-X LINEARITY CONTROL, MODEL A81196, Substantially Equivalent on 2010-12-21. 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: 2010-03-22
Decision date: 2010-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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