C-REACTIVE PROTEIN (CRP)— 510(k) K030899

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K030899 for C-REACTIVE PROTEIN (CRP), Substantially Equivalent on 2003-07-02. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2003-03-24
Decision date: 2003-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.