Roche Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Roche Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P160019S013 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II	2021-12-16
PMA P160019S012 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg Confirmatory Test	2021-12-09
PMA P160019S011 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II Auto Confirm	2020-10-19
PMA P160019S010 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II	2020-02-27
PMA P160019S009 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II	2019-04-24
PMA P160019S008 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II (100/200 tests)	2018-11-06
PMA P160019S007 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II	2018-06-13
PMA P160019S003 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II	2018-01-18
PMA P160019S004 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II	2017-12-29
PMA P160019S006 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II	2017-12-20
PMA P160019S001 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II	2017-11-01
PMA P160019S005 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II	2017-08-31
PMA P160019S002 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II (100/200 tests) Immunoassay	2017-06-23
PMA P160019 ROCHE DIAGNOSTICS, INC.	Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II	2016-12-23

Similar & Related FDA Registered Companies

• ROCHE DIAGNOSTICS OPERATIONS INC.
• ROCHE DIAGNOSTICS CORP, INC.
• Roche Diagnostics Hematology, Inc.