Diatron Group, a Hungary-based hematology analyzers and reagents for the human medical and veterinary markets, has received FDA 510k approval for Pictus 400, a clinical chemistry analyzer that can be used in small to medium sized hospitals and clinics.
The Pictus 400 represents Diatron’s first of many clinical products that are planned to be launched in the US market this year.
According to the company, the clinical chemistry analyzer can perform up to 400 tests per hour with (ISE) capability.
Diatron, a portfolio company of New York-and-Cleveland-based private equity firm The Riverside Company, said its Metrolab Division will manufacture the Pictus 400
The analyzer will be distributed under the company’s brand in the US, where the company is currently seeking qualified distribution partners.
CEO Jim Schepp said they have the infrastructure in place to support distributors and their customers.
"In the near future, we will be introducing additional chemistry instruments and our line of hematology instruments once we have received FDA approval," Schepp said.