Cleared Traditional

PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM

K091052 · Abaxis, Inc. · Immunology
Jan 2010
Decision
277d
Days
Class 2
Risk

About This 510(k) Submission

K091052 is an FDA 510(k) clearance for the PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on January 15, 2010, 277 days after receiving the submission on April 13, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K091052 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2009
Decision Date January 15, 2010
Days to Decision 277 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DCN — System, Test, C-reactive Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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