Cleared Traditional

PAROS CRP

K022690 · Horiba, Ltd. · Immunology

Dec 2002

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K022690 is an FDA 510(k) clearance for the PAROS CRP, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Horiba, Ltd. (Irvine, US). The FDA issued a Cleared decision on December 23, 2002, 132 days after receiving the submission on August 13, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K022690 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 2002
Decision Date	December 23, 2002
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF