Cleared Special

SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM

K130138 · Roche Diagnostics Corp. · Chemistry
Mar 2013
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K130138 is an FDA 510(k) clearance for the SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on March 15, 2013, 56 days after receiving the submission on January 18, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K130138 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2013
Decision Date March 15, 2013
Days to Decision 56 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NBW — System, Test, Blood Glucose, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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