FDA 510(k) Applications Submitted by HELEN T TORNEY

FDA 510(k) Number Submission Date Device Name Applicant
K013278 10/01/2001 TINA-QUANT APOLIPOPROTEIN A-1 VER.2 ROCHE DIAGNOSTICS CORP.
K010237 01/25/2001 ELECSYS HCG+B CALCHECK ROCHE DIAGNOSTICS CORP.
K011658 05/29/2001 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS ROCHDIAG
K012359 07/25/2001 TINA-QUANT COMPLEMENT C4 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K012361 07/25/2001 TINA-QUANT COMPLEMENT C3C TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K013249 09/28/2001 TINA-QUANT APOLIPOPROTEIN VER.2 ROCHE DIAGNOSTICS CORP.


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