Connecticut Diagnostics, Ltd.: FDA clearances and approvals
Connecticut Diagnostics, Ltd. has 14 FDA 510(k) clearances (first 1979, latest 1991), across 12 product codes in 3 review panels. Median 510(k) review time: 17 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Connecticut Diagnostics, Ltd. have?
Connecticut Diagnostics, Ltd. has 14 FDA 510(k) clearances (first 1979, latest 1991), across 12 product codes in 3 review panels.
How long does FDA take to clear Connecticut Diagnostics, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Connecticut Diagnostics, Ltd.'s cleared 510(k)s is 17 days.
What devices does Connecticut Diagnostics, Ltd. make?
Its most frequent FDA product codes are CIG (Diazo Colorimetry, Bilirubin, 2); GGK (Products, Red-Cell Lysing Products, 2); CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase, 1).
Has Connecticut Diagnostics, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Connecticut Diagnostics, Ltd. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.