Hamilton Co.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Hamilton Co.” (first 1980, latest 1996), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 47 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 | 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | 6 | 6 |
| JTC | Device, Microtiter Diluting/Dispensing | 3 | 3 |
| DJY | Ion-Exchange Chromatography | 1 | 1 |
| DMZ | Liquid Chromatography, Adsorbent | 1 | 1 |
| DNH | Resins, Ion-Exchange, Liquid Chromatography | 1 | 1 |
| DPM | Columns, Liquid Chromatography | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| KZR | Chromatography (Liquid, Gel), Clinical Use | 1 | 1 |
Review panels
Most recent Hamilton Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961896 | MICROLAB 4000, MICROLAB 4200 | JQW | 1996-08-16 | 92 |
| K943493 | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | JJE | 1995-01-30 | 195 |
| K892369 | MULTI-PROBE HEAD PLUS | JTC | 1989-06-02 | 57 |
| K873893 | LUMICON | JJQ | 1988-01-05 | 104 |
| K871945 | MICROLAB AT | JTC | 1987-05-29 | 10 |
| K832205 | PRECISION LIQUID DISPENSER | JQW | 1983-08-24 | 48 |
| K832204 | MICROLAB P | JQW | 1983-08-24 | 48 |
| K832202 | PB 600 REPEATING DISPENSER | JQW | 1983-08-24 | 48 |
| K832201 | CHROM-PREP | KZR | 1983-08-16 | 40 |
| K832200 | PRP-1 REVERSED PHASE COLUMNS FOR HPLC | DPM | 1983-08-16 | 40 |
6 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 11 recall events; 0 initiated in the last five years. Most recent: 2021-01-15.
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.
- Hamilton Medical AG (30 510(k)s)
- Hamilton Medical, Inc. (15 510(k)s)
- Hamilton Thorne, Inc. (6 510(k)s)
- Hamilton Industries, Inc. (5 510(k)s)
- Hamilton Thorne Research (5 510(k)s)
- Hamilton Thorne Biosciences (2 510(k)s)
- Hamilton Kent (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hamilton Co.?
FDA lists 16 510(k) clearances under the applicant name “Hamilton Co.” (first 1980, latest 1996), across 9 product codes in 3 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 Hamilton Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hamilton Co. is 47 days.
Which FDA product codes appear under Hamilton Co.?
The most frequent FDA product codes under this applicant name are JQW (Station, Pipetting And Diluting, For Clinical Use, 6); JTC (Device, Microtiter Diluting/Dispensing, 3); DJY (Ion-Exchange Chromatography, 1).
Next steps
- See all 16 Hamilton Co. clearances with predicates and recalls
- Run predicate analysis for product code JQW, Hamilton Co.'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.