IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT— 510(k) K071002

Name: FDA 510(k) clearance K071002
Creator: U.S. Food and Drug Administration
Published: 2007-06-21

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K071002 for IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT, Substantially Equivalent on 2007-06-21. 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: 2007-04-09
Decision date: 2007-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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