SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR— 510(k) K994169

Name: FDA 510(k) clearance K994169
Creator: U.S. Food and Drug Administration
Published: 2000-02-03

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K994169 for SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR, Substantially Equivalent on 2000-02-03. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1999-12-10
Decision date: 2000-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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