Orgentec Diagnostika GmbH

Medical device manufacturer in East Stroudsburg, PA.

3510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K100499Orgentec Rheumatoid Factor EiaDHR · Traditional 10/27/2010SE
K092399Anti-Mutated Citrullinated Vimentin EiaOQZ · Traditional 07/01/2010SE
K030929Ana DetectLJM · Traditional 05/02/2003SE