MODIFICATION TO SYNCHRON CONTROL— 510(k) K013235

Name: FDA 510(k) clearance K013235
Creator: U.S. Food and Drug Administration
Published: 2001-10-16

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K013235 for MODIFICATION TO SYNCHRON CONTROL, Substantially Equivalent on 2001-10-16. Applicant: Beckman Coulter, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2001-09-28
Decision date: 2001-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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