Connecticut Diagnostics, Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Connecticut Diagnostics, Ltd.” (first 1979, latest 1991), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 17 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| GGK | Products, Red-Cell Lysing Products | 2 | 2 |
| CED | 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
| GIF | Diluent, Blood Cell | 1 | 1 |
| JGZ | O-Phthalaldehyde, Urea Nitrogen | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Chemistry (10)
- Hematology (3)
- Microbiology (1)
Most recent Connecticut Diagnostics, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905617 | VISI-STAPH | JWX | 1991-03-29 | 105 |
| K822504 | CDL AUTO-LYSING REAGENT | GGK | 1982-09-17 | 29 |
| K822501 | CDL ISOTONIC DILUENT | GIF | 1982-09-17 | 30 |
| K822500 | CDL LYSING REAGENT | GGK | 1982-09-17 | 30 |
| K811222 | INORGANIC PHOSPHORUS REAGENTS | CED | 1981-05-21 | 17 |
| K801898 | URIC ACID DIAGNOSTIC REAGENT | KNK | 1980-10-10 | 63 |
| K801897 | GLUCOSE DIAGNOSTIC REAGENT | CGA | 1980-10-10 | 63 |
| K792465 | CONNECTICUT DIAGNOSTICS, LTS. DIRECT | CIG | 1979-12-18 | 15 |
| K792362 | BLOOD UREA NITROGEN REAGENT | JGZ | 1979-12-06 | 15 |
| K792340 | CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE | CEK | 1979-12-06 | 17 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Connecticut Diagnostics, Ltd..
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.
- Connecticut Bioinstruments, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Connecticut Diagnostics, Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Connecticut Diagnostics, Ltd.” (first 1979, latest 1991), across 12 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 Connecticut Diagnostics, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Connecticut Diagnostics, Ltd. is 17 days.
Which FDA product codes appear under Connecticut Diagnostics, Ltd.?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 2); GGK (Products, Red-Cell Lysing Products, 2); CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase, 1).
Next steps
- See all 14 Connecticut Diagnostics, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CIG, Connecticut Diagnostics, Ltd.'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.