ACCU-CHEK Guide Blood Glucose Monitoring System
K-Number: K160944 · 2016-08-31
ApplicantRoche Diabetes Care, Inc.
Decision Date2016-08-31
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
ACCU-CHEK Guide Blood Glucose Monitoring System is a medical device manufactured by Roche Diabetes Care, Inc.. It received FDA 510(k) clearance on 2016-08-31 under approval number K160944. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ACCU-CHEK Guide Blood Glucose Monitoring System?
ACCU-CHEK Guide Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-08-31. It is manufactured by Roche Diabetes Care, Inc.. The 510(k) number is K160944.
When was ACCU-CHEK Guide Blood Glucose Monitoring System approved by the FDA?
ACCU-CHEK Guide Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-08-31, under approval number K160944.
What company makes ACCU-CHEK Guide Blood Glucose Monitoring System?
ACCU-CHEK Guide Blood Glucose Monitoring System is manufactured by Roche Diabetes Care, Inc..
What is the FDA product code for ACCU-CHEK Guide Blood Glucose Monitoring System?
The FDA product code for ACCU-CHEK Guide Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.