October 31, 2012 - South Burlington, VT
Data Innovations (DI) announces that they have received approval from the Department of Health & Human Services, which is a division of the FDA, stating that Instrument Manager (IM) v8.12.01 has received 510(k) clearance and can be sold and used in Blood Bank Environments.
Data Innovations has already received 510(k) clearance for previous versions of IM, versions 8.05, 8.07, 8.10 and now 8.12. The recent submission was a cumulative one that included all changes since the IM v8.10 submission. In addition to IM, there have also been over a dozen drivers that have also received clearance.
Although it is not required to apply for 510(k) clearance, DI continues to do so to allow the product to be used in specialized markets like blood banking.