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Fisher Diagnostics

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K170652 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 ControlsPRI2017-06-01 View
510(k) K070640 ARCHITECT STAT TROPONIN-1; MYOGLOBINMMI2007-09-13 View
510(k) K052407 ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSJZO2006-07-18 View
510(k) K052308 ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMJZO2006-05-10 View
510(k) K042924 ARCHITECT STAT MYO IMMUNOASSAYDDR2005-01-24 View
510(k) K041192 ARCHITECT STAT TROPONIN-I IMMUNOASSAYMMI2004-08-12 View
510(k) K041596 ARCHITECT STAT CK-MB IMMUNOASSAYJHX2004-07-21 View
510(k) K023362 FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLINGKP2002-12-09 View
510(k) K013397 PACIFIC HEMOSTASIS REFERENCE EMULSIONJIX2002-02-15 View
510(k) K010750 PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560GGN2001-09-07 View
510(k) K850160 FISHER DIAGNOSTICS LATEST-CRP TEST KITDCK1985-04-19 View
510(k) K844346 FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TESJHJ1985-03-04 View
510(k) K844347 FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KITJHJ1985-01-23 View
510(k) K844047 FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORSJIT1984-11-09 View
510(k) K840921 THERACHEM TDC THERAPEUTIC DRUG CONTROLDIF1984-04-05 View
510(k) K833514 TOXI CHEM SERUM ALCOHOL CONTROLDKC1983-12-08 View
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