SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR— 510(k) K021572

Name: FDA 510(k) clearance K021572
Creator: U.S. Food and Drug Administration
Published: 2002-07-19

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K021572 for SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR, Substantially Equivalent on 2002-07-19. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2002-05-14
Decision date: 2002-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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