This page includes the latest FDA filings for Siemens Healthcare Diagnostics Inc 511 Benedict Avenuetarrytown Ny 10591 Pma Numberp210019 Supplement Numbers001 Date Received08 01 2022 Decision Date12 20 2022 Product Code Lom Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
| Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591 PMA NumberP210019 Supplement NumberS001 Date Received08/01/2022 Decision Date12/20/2022 Product Code LOM Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No | ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC) | 2022-12-20 |