Compliance Consultants has submitted Class II claims for
non-invasive & minimally invasive blood glucose monitors.
10 years ago we worked with Dr. Stephen Gutman (head of the FDA/CDRH clinical laboratory equipment division) in presenting a noninvasive blood glucose detector that did work on normal people - but in clinical trials - it was discovered - it failed to respond to dramatic changes in blood glucose levels. This application was the cause that elevated all noninvasive blood glucose detectors into the Class III category.
10 years ago we worked with Dr. Stephen Gutman (head of the FDA/CDRH clinical laboratory equipment division) in presenting a noninvasive blood glucose detector that did work on normal people - but in clinical trials - it was discovered - it failed to respond to dramatic changes in blood glucose levels. This application was the cause that elevated all noninvasive blood glucose detectors into the Class III category.
