This page includes the latest FDA filings for Siemens Healthcare Diagnostics Products Ltdglyn Rhonwyllanberis Caernarfon Ll55 Pma Numberp010050 Supplement Numbers021 Date Received09 15 2022 Decision Date10 14 2022 Product Code Lom Advisory Committee Microbiology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier 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 Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010050 Supplement NumberS021 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No | IMMULITE® 2000 HBsAg and IMMULITE® 2000 HBsAg Confirmatory Kit’ | 2022-10-14 |