Innovus Pharmaceuticals (OTC:INNV) said today that its GlucoGorx glucose monitoring kit, which includes a glucose meter, test strips and a lancet device, won 510(k) approval from the FDA.
The San Diego, Calif.-based company plans to launch its blood sugar monitoring kit in the second half of this year.
“We are very happy to be announcing the FDA clearance of the GlucoGorx Kit which is our second FDA cleared device in the US. The creation of a kit for monitoring a diabetic’s blood sugar levels expands our GlucoGorx clinical supplement offerings,” president & CEO Bassam Damaj said in prepared remarks.
Innovus announced that it agreed to sell Acon Laboratories’ GlucoGorx kit in November last year. The company touted the system as being able to provide a user’s blood glucose levels within four seconds.
