Fisher Diagnostics: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Fisher Diagnostics” (first 1983, latest 2017), across 13 product codes in 5 review panels. Median 510(k) review time under this name: 94 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 90 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fisher Diagnostics took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 | 1 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| DKC | Alcohol Control Materials | 1 | 1 |
| GGN | Plasma, Coagulation Control | 1 | 1 |
| GKP | Instrument, Coagulation, Automated | 1 | 1 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (7)
- Immunology (4)
- Hematology (2)
- Clinical Toxicology (2)
- Microbiology (1)
Most recent Fisher Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 | PRI | 2017-06-01 | 90 |
| K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | MMI | 2007-09-13 | 190 |
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | JZO | 2006-07-18 | 320 |
| K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | JZO | 2006-05-10 | 259 |
| K042924 | ARCHITECT STAT MYO IMMUNOASSAY | DDR | 2005-01-24 | 94 |
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY | MMI | 2004-08-12 | 98 |
| K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY | JHX | 2004-07-21 | 37 |
| K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | GKP | 2002-12-09 | 63 |
| K013397 | PACIFIC HEMOSTASIS REFERENCE EMULSION | JIX | 2002-02-15 | 123 |
| K010750 | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 | GGN | 2001-09-07 | 178 |
6 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2025-03-06.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fisher Scientific Co., LLC (89 510(k)s)
- Fisher & Paykel Healthcare, Ltd. (82 510(k)s)
- Fisher & Paykel Electronics , Ltd. (17 510(k)s)
- Fisher & Paykel Allied Products , Ltd. (12 510(k)s)
- Fisher & Paykel Healthcare (5 510(k)s)
- Fisher Imaging Corp. (3 510(k)s)
- Fisher Price (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fisher Diagnostics?
FDA lists 16 510(k) clearances under the applicant name “Fisher Diagnostics” (first 1983, latest 2017), across 13 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fisher Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fisher Diagnostics is 94 days.
Which FDA product codes appear under Fisher Diagnostics?
The most frequent FDA product codes under this applicant name are JHJ (Agglutination Method, Human Chorionic Gonadotropin, 2); JZO (System, Test, Thyroid Autoantibody, 2); MMI (Immunoassay Method, Troponin Subunit, 2).
Next steps
- See all 16 Fisher Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JHJ, Fisher Diagnostics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.