SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT— 510(k) K070626

Name: FDA 510(k) clearance K070626
Creator: U.S. Food and Drug Administration
Published: 2007-05-04

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K070626 for SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT, Substantially Equivalent on 2007-05-04. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code NQD
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2007-03-06
Decision date: 2007-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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