FDA 510(k) Applications Submitted by Fisher Diagnostics

FDA 510(k) Number Submission Date Device Name Applicant
K170652 03/03/2017 ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls Fisher Diagnostics
K070640 03/07/2007 ARCHITECT STAT TROPONIN-1; MYOGLOBIN FISHER DIAGNOSTICS
K023362 10/07/2002 FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN FISHER DIAGNOSTICS
K013397 10/15/2001 PACIFIC HEMOSTASIS REFERENCE EMULSION FISHER DIAGNOSTICS
K041192 05/06/2004 ARCHITECT STAT TROPONIN-I IMMUNOASSAY FISHER DIAGNOSTICS
K041596 06/14/2004 ARCHITECT STAT CK-MB IMMUNOASSAY FISHER DIAGNOSTICS
K042924 10/22/2004 ARCHITECT STAT MYO IMMUNOASSAY FISHER DIAGNOSTICS
K052308 08/24/2005 ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM FISHER DIAGNOSTICS
K052407 09/01/2005 ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS FISHER DIAGNOSTICS
K010750 03/13/2001 PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 FISHER DIAGNOSTICS


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