Cleared Traditional

CONTOUR? PLUS BLUE Blood Glucose Monitoring System; CONTOUR? NEXT GEN Blood Glucose Monitoring System

K241787 · Ascensia Diabetes Care U.S., Inc. · Chemistry
Aug 2024
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K241787 is an FDA 510(k) clearance for the CONTOUR? PLUS BLUE Blood Glucose Monitoring System; CONTOUR? NEXT GEN Blood Glucose Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Ascensia Diabetes Care U.S., Inc. (Parsippany, US). The FDA issued a Cleared decision on August 27, 2024, 67 days after receiving the submission on June 21, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K241787 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2024
Decision Date August 27, 2024
Days to Decision 67 days
Submission Type Traditional
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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