Fisher Scientific Co., LLC: FDA filings under this applicant name
FDA lists 89 510(k) clearances under the applicant name “Fisher Scientific Co., LLC” (first 1976, latest 1993), plus 1 PMA decision, across 51 product codes in 6 review panels. Median 510(k) review time under this name: 35 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Thermo Fisher Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 15 | 15 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 | 5 |
| JPK | Mixture, Hematology Quality Control | 5 | 5 |
| DIF | Drug Mixture Control Materials | 4 | 4 |
| JGS | Electrode, Ion Specific, Sodium | 3 | 3 |
| CEK | Biuret (Colorimetric), Total Protein | 2 | 2 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 2 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 2 |
| GKF | Instrument, Hematocrit, Automated | 2 | 2 |
Plus 41 more product codes.
Review panels
- Clinical Chemistry (63)
- Hematology (14)
- Microbiology (4)
- Pathology (4)
- Clinical Toxicology (4)
- Immunology (1)
Most recent Fisher Scientific Co., LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K930415 | MICROHEMATOCRIT ROTOR | GKG | 1993-03-23 | 56 |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | GKF | 1992-03-11 | 72 |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | GKF | 1992-01-08 | 35 |
| K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 | JJW | 1989-03-08 | 41 |
| K881275 | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II | JJY | 1988-05-16 | 52 |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | GGK | 1987-10-20 | 15 |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | KPA | 1987-09-14 | 52 |
| K871058 | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) | JJY | 1987-04-06 | 20 |
| K863224 | HEMATALL-C PLUS HEMATOLOGY CONTROLS | JPK | 1986-10-29 | 69 |
| K862318 | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR | JPK | 1986-07-10 | 22 |
79 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P770001 | PMA | FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) | 1979-07-18 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-02-05.
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 & Paykel Healthcare, Ltd. (75 510(k)s)
- Fisher & Paykel Electronics , Ltd. (17 510(k)s)
- Fisher Diagnostics (16 510(k)s)
- Fisher & Paykel Allied Products , Ltd. (12 510(k)s)
- Fisher & Paykel Healthcare Limited (8 510(k)s)
- Fisher and Paykel Healthcare Limited (4 510(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 Scientific Co., LLC?
FDA lists 89 510(k) clearances under the applicant name “Fisher Scientific Co., LLC” (first 1976, latest 1993), plus 1 PMA decision, across 51 product codes in 6 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 Scientific Co., LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fisher Scientific Co., LLC is 35 days.
Which FDA product codes appear under Fisher Scientific Co., LLC?
The most frequent FDA product codes under this applicant name are CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 15); JJY (Multi-Analyte Controls, All Kinds (Assayed), 5); JPK (Mixture, Hematology Quality Control, 5).
Next steps
- See all 89 Fisher Scientific Co., LLC clearances with predicates and recalls
- Run predicate analysis for product code CHL, Fisher Scientific Co., LLC'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.