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Fisher Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
16
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1503-2025Class IIPacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and fMarch 6, 2025
Z-1502-2025Class IIPacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and faMarch 6, 2025
Z-2762-2017Class IIPacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 10May 19, 2017
Z-2763-2017Class IIPacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --May 19, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlJune 1, 2017
K070640ARCHITECT STAT TROPONIN-1; MYOGLOBINSeptember 13, 2007
K052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSJuly 18, 2006
K052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMMay 10, 2006
K042924ARCHITECT STAT MYO IMMUNOASSAYJanuary 24, 2005
K041192ARCHITECT STAT TROPONIN-I IMMUNOASSAYAugust 12, 2004
K041596ARCHITECT STAT CK-MB IMMUNOASSAYJuly 21, 2004
K023362FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLINDecember 9, 2002
K013397PACIFIC HEMOSTASIS REFERENCE EMULSIONFebruary 15, 2002
K010750PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560September 7, 2001
K850160FISHER DIAGNOSTICS LATEST-CRP TEST KITApril 19, 1985
K844346FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TESMarch 4, 1985
K844347FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KITJanuary 23, 1985
K844047FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORSNovember 9, 1984
K840921THERACHEM TDC THERAPEUTIC DRUG CONTROLApril 5, 1984
K833514TOXI CHEM SERUM ALCOHOL CONTROLDecember 8, 1983