Fisher Diagnostics
Fisher Diagnostics holds FDA 510(k) medical device clearances, first cleared 1983, most recent 2017, with 4 FDA device recalls on record.
Top product codes for Fisher Diagnostics
FDA recalls by Fisher Diagnostics
- Z-1503-2025 — Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
- Z-1502-2025 — Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays.
- Z-2762-2017 — Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
- Z-2763-2017 — Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Fisher Diagnostics
- 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 Controls
- K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN
- K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
- K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
- K042924 — ARCHITECT STAT MYO IMMUNOASSAY
- K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY
- K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY
- K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN
- K013397 — PACIFIC HEMOSTASIS REFERENCE EMULSION
- K010750 — PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
- K850160 — FISHER DIAGNOSTICS LATEST-CRP TEST KIT
- K844346 — FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES
- K844347 — FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
- K844047 — FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS
- K840921 — THERACHEM TDC THERAPEUTIC DRUG CONTROL
- K833514 — TOXI CHEM SERUM ALCOHOL CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.