Instrument Manager™ 8.12.01 Receives 510(k) Clearance

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.

Share this post

About Us

At Data Innovations, we believe that when we enable clinical labs of every size to harness innovation and optimize performance across all disciplines, we empower them to focus on what matters most: their patients. Our leading solutions, world-class service, and support for an open ecosystem transform lab enterprise management.

Data Innovations has been the industry leader for more than 30 years. We are a global software company, serving 6,000+ hospitals and laboratories in 85+ countries.