Gilford Instrument Laboratories, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Gilford Instrument Laboratories, Inc.” (first 1976, latest 1982), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 34 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 7 | 7 |
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | 2 | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 | 2 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 | 1 |
| JJI | Analyzer, Enzyme, For Clinical Use | 1 | 1 |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 1 | 1 |
| JJO | Flame Emission Photometer For Clinical Use | 1 | 1 |
| JRI | Cuvette, Thermostated | 1 | 1 |
Review panels
- Clinical Chemistry (16)
Most recent Gilford Instrument Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823233 | SBA 300 CLINICAL CHEMISTRY ANALYZER | JJC | 1982-11-29 | 31 |
| K821583 | AMES/GILFORD OPTIMATE CLIN. CHEM & THER | JJF | 1982-06-24 | 27 |
| K802609 | CHEMISTRY ANALYZER IMPACT 400 | JJE | 1980-11-26 | 36 |
| K801889 | MODEL 203S CLINICAL CHEMISTRY ANALYZER | JJE | 1980-09-26 | 49 |
| K800085 | SYSTEM 203 CHEMISTRY ANALYZER | JJE | 1980-02-13 | 30 |
| K792361 | SYSTEM 103 CHEMISTRY ANALYZER | JJE | 1979-12-27 | 36 |
| K792087 | MICROFLAME PHOTOMETER | JJO | 1979-11-13 | 27 |
| K791968 | EIA (ELISA) READER | JJQ | 1979-10-17 | 16 |
| K790073 | ANALYZER, IMPACT 100 | JJI | 1979-02-22 | 42 |
| K790072 | ANALYZER, IMPACT 200 | JJE | 1979-02-22 | 42 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gilford Instrument Laboratories, Inc..
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.
- Gilford Diagnostics (50 510(k)s)
- Gilford (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gilford Instrument Laboratories, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Gilford Instrument Laboratories, Inc.” (first 1976, latest 1982), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gilford Instrument Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gilford Instrument Laboratories, Inc. is 34 days.
Which FDA product codes appear under Gilford Instrument Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 7); JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use, 2); JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 2).
Next steps
- See all 16 Gilford Instrument Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJE, Gilford Instrument Laboratories, Inc.'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.