Induo Blood Glucose Meter
by Inverness Medical Innovations, Inc.
510(k) K011616
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011616 | Date21 Jun 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NBW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Induo Blood Glucose Meter is a device designed to measure the concentration of glucose in the blood. It provides quantitative readings to assist in the monitoring and management of blood glucose levels.
This device is authorized under FDA 510K clearance. It is identified by the K011616 submission and is categorized under the clinical chemistry advisory committee.
Other devices from Inverness Medical Innovations, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the primary function of the Induo Blood Glucose Meter?
The Induo Blood Glucose Meter is designed to measure the concentration of glucose in the blood. It provides quantitative readings that are intended to assist patients and clinicians in the monitoring and management of blood glucose levels.
What is the regulatory status of this device?
The Induo Blood Glucose Meter is authorized under FDA 510K clearance, identified by submission number K011616. The device was determined to be substantially equivalent under the clinical chemistry advisory committee.
Who is the manufacturer of the Induo Blood Glucose Meter?
The device is manufactured by Inverness Medical Innovations, Inc., located in Waltham, Massachusetts. The company submitted the device for review, which resulted in a decision date of June 21, 2001.