SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291— 510(k) K091153

Name: FDA 510(k) clearance K091153
Creator: U.S. Food and Drug Administration
Published: 2009-07-13

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K091153 for SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291, Substantially Equivalent on 2009-07-13. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 2009-04-21
Decision date: 2009-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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