FDA 510(k), K181131, Accu-Chek Guide Me Blood Glucose Monitoring System

510(K) Number: K181131
Device Name: Accu-Chek Guide Me Blood Glucose Monitoring System
Manufacturer: Roche Diabetes Care
Device Classification Name: System, Test, Blood Glucose, Over The Counter
Regulation Number: 862.1345
Classification Product Code: NBW
Date Received: 04/30/2018
Decision Date: 12/13/2018
Regulation Medical Specialty: Clinical Chemistry

461 pages (1,546 of 2,007 original pages are fully redacted)