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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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