Fisher Diagnostics
Medical device manufacturer in Middletown, VA.
16510(k) clearances
0PMA approvals
4recalls
Device types
- JHJ Agglutination Method, Human Chorionic… 2
- MMI Immunoassay Method, Troponin Subunit 2
- JZO System, Test, Thyroid Autoantibody 2
- DKC Alcohol Control Materials 1
- DIF Drug Mixture Control Materials 1
- JIT Calibrator, Secondary 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- GGN Plasma, Coagulation Control 1
- JIX Calibrator, Multi-Analyte Mixture 1
- GKP Instrument, Coagulation, Automated 1
- JHX Fluorometric Method, Cpk Or Isoenzymes 1
- DDR Myoglobin, Antigen, Antiserum, Control 1
- PRI Procalcitonin Assay 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| 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…PRI · Traditional | 06/01/2017SE |
| K070640 | Architect Stat TROPONIN-1; MyoglobinMMI · Special | 09/13/2007SE |
| K052407 | Architect Anti-Tpo Immunoassay, Calibrators & ControlsJZO · Traditional | 07/18/2006SE |
| K052308 | Architect Anti-Tg Immunoassay Reagents, Calibrators, Controls and System Assay Cd-RomJZO · Traditional | 05/10/2006SE |
| K042924 | Architect Stat Myo ImmunoassayDDR · Traditional | 01/24/2005SE |
| K041192 | Architect Stat Troponin-I ImmunoassayMMI · Traditional | 08/12/2004SE |
| K041596 | Architect Stat Ck-Mb ImmunoassayJHX · Traditional | 07/21/2004SE |
| K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinGKP · Traditional | 12/09/2002SE |
| K013397 | Pacific Hemostasis Reference EmulsionJIX · Traditional | 02/15/2002SE |
| K010750 | Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560GGN · Traditional | 09/07/2001SE |
| K850160 | Fisher Diagnostics Latest-Crp Test KitDCK · Traditional | 04/19/1985SE |
| K844346 | Fisher Diagnostics Pregnaclone Slide Pregnancy TesJHJ · Traditional | 03/04/1985SE |
| K844347 | Fisher Diag. Pregnaclone Tube Pregnancy Test KitJHJ · Traditional | 01/23/1985SE |
| K844047 | Fisher Diagnostics Sera Chem Smac CalibratorsJIT · Traditional | 11/09/1984SE |
| K840921 | Therachem TDC Therapeutic Drug ControlDIF · Traditional | 04/05/1984SE |
| K833514 | Toxi Chem Serum Alcohol ControlDKC · Traditional | 12/08/1983SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1503-2025 Class II | Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin…The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. | 03/06/2025Open, Classified |
| Z-1502-2025 Class II | Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time…The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. | 03/06/2025Open, Classified |
| Z-2763-2017 Class II | Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5…An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number… | 05/19/2017Terminated |
| Z-2762-2017 Class II | Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations)…An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number… | 05/19/2017Terminated |