Published on: 2023-24717. Final amendment; final order. 2023-24717. Medical Devices; Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions
Published on: 2023-02141. Final amendment; final order. 2023-02141. Medical Devices; Hematology and Pathology Devices; Classification of the Software Algorithm Device To Assist Users in Digital Pathology
Published on: 2019-03967. Proposed order; request for comments. 2019-03967. Medical Devices; Exemption From Premarket Notification: Class II Devices; Flow Cytometer Instruments; Request for Comments
Published on: 2018-10610. Final rule. 2018-10610. Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
Published on: 2017-28342. Final order. 2017-28342. Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System