FDA 510(k) Applications Submitted by ROCHE DIAGNOSTICS GMBH

FDA 510(k) Number Submission Date Device Name Applicant
K143446 12/02/2014 Accu-Chek FlexLink Plus infusion set Roche Diagnostics GmbH
K981281 04/08/1998 ELECSYS CALCHECK FERRITIN ROCHE DIAGNOSTICS GMBH
K981278 04/08/1998 ELECSYS CALCHECK CA 125II ROCHE DIAGNOSTICS GMBH
K981282 04/08/1998 ELECSYS AFP ROCHE DIAGNOSTICS GMBH


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact