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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.
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