On Call Pro Blood Glucose Monitoring System
K-Number: K161867 · 2016-08-05
ApplicantAcon Laboratories
Decision Date2016-08-05
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
On Call Pro Blood Glucose Monitoring System is a medical device manufactured by Acon Laboratories. It received FDA 510(k) clearance on 2016-08-05 under approval number K161867. 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 On Call Pro Blood Glucose Monitoring System?
On Call Pro Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-08-05. It is manufactured by Acon Laboratories. The 510(k) number is K161867.
When was On Call Pro Blood Glucose Monitoring System approved by the FDA?
On Call Pro Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-08-05, under approval number K161867.
What company makes On Call Pro Blood Glucose Monitoring System?
On Call Pro Blood Glucose Monitoring System is manufactured by Acon Laboratories.
What is the FDA product code for On Call Pro Blood Glucose Monitoring System?
The FDA product code for On Call Pro 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.