Company ยท US
Fisher Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2017. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GJS | Test, Time, Prothrombin | 2 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| KQJ | System, Fibrinogen Determination | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| DIF | Drug Mixture Control Materials | 1 |
| DKC | Alcohol Control Materials | 1 |
| GGN | Plasma, Coagulation Control | 1 |
| GKP | Instrument, Coagulation, Automated | 1 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 1 |
| JIT | Calibrator, Secondary | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| PRI | Procalcitonin Assay | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 1, 2017 | 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 Fisher Diagnostics | PRI |
| Sep 13, 2007 | K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN Fisher Diagnostics | MMI |
| Jul 18, 2006 | K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS Fisher Diagnostics | JZO |
| May 10, 2006 | K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM Fisher Diagnostics | JZO |
| Jan 24, 2005 | K042924 | ARCHITECT STAT MYO IMMUNOASSAY Fisher Diagnostics | DDR |
| Aug 12, 2004 | K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY Fisher Diagnostics | MMI |
| Jul 21, 2004 | K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY Fisher Diagnostics | JHX |
| Dec 9, 2002 | K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN Fisher Diagnostics | GKP |
| Feb 15, 2002 | K013397 | PACIFIC HEMOSTASIS REFERENCE EMULSION Fisher Diagnostics | JIX |
| Sep 7, 2001 | K010750 | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 Fisher Diagnostics | GGN |
| Apr 19, 1985 | K850160 | FISHER DIAGNOSTICS LATEST-CRP TEST KIT Fisher Diagnostics | DCK |
| Mar 4, 1985 | K844346 | FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES Fisher Diagnostics | JHJ |
| Jan 23, 1985 | K844347 | FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT Fisher Diagnostics | JHJ |
| Nov 9, 1984 | K844047 | FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS Fisher Diagnostics | JIT |
| Apr 5, 1984 | K840921 | THERACHEM TDC THERAPEUTIC DRUG CONTROL Fisher Diagnostics | DIF |
| Dec 8, 1983 | K833514 | TOXI CHEM SERUM ALCOHOL CONTROL Fisher Diagnostics | DKC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2025 | Fisher Diagnostics Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays. Open, Classified |
GJS | K994100 |
| Mar 31, 2025 | Fisher Diagnostics Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays. Open, Classified |
GJS | K994100 |
| May 19, 2017 | Fisher Diagnostics 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 Scientif Terminated |
KQJ | K800826 |
| May 19, 2017 | Fisher Diagnostics 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 Terminated |
KQJ | K800826 |