Cleared Abbreviated

ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM

K080227 · Roche Diagnostics Corp. · General Hospital
May 2008
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K080227 is an FDA 510(k) clearance for the ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on May 15, 2008, 106 days after receiving the submission on January 30, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K080227 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2008
Decision Date May 15, 2008
Days to Decision 106 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MRZ — Accessories, Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725