Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Connecticut Diagnostics, Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
17 daysmedian FDA review time
63 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K905617 | VISI-STAPH | Connecticut Diagnostics, Ltd. | 1991-03-29 | 105 | 0 |
| K822500 | CDL LYSING REAGENT | Connecticut Diagnostics, Ltd. | 1982-09-17 | 30 | 0 |
| K822501 | CDL ISOTONIC DILUENT | Connecticut Diagnostics, Ltd. | 1982-09-17 | 30 | 0 |
| K822504 | CDL AUTO-LYSING REAGENT | Connecticut Diagnostics, Ltd. | 1982-09-17 | 29 | 0 |
| K811222 | INORGANIC PHOSPHORUS REAGENTS | Connecticut Diagnostics, Ltd. | 1981-05-21 | 17 | 0 |
| K801897 | GLUCOSE DIAGNOSTIC REAGENT | Connecticut Diagnostics, Ltd. | 1980-10-10 | 63 | 0 |
| K801898 | URIC ACID DIAGNOSTIC REAGENT | Connecticut Diagnostics, Ltd. | 1980-10-10 | 63 | 0 |
| K792465 | CONNECTICUT DIAGNOSTICS, LTS. DIRECT | Connecticut Diagnostics, Ltd. | 1979-12-18 | 15 | 0 |
| K792362 | BLOOD UREA NITROGEN REAGENT | Connecticut Diagnostics, Ltd. | 1979-12-06 | 15 | 0 |
| K792340 | CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE | Connecticut Diagnostics, Ltd. | 1979-12-06 | 17 | 0 |
| K792338 | DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS | Connecticut Diagnostics, Ltd. | 1979-12-06 | 17 | 0 |
| K792337 | DONNECT. DIAG. CALCIUM DIAG. REAGENT | Connecticut Diagnostics, Ltd. | 1979-12-06 | 17 | 0 |
| K792339 | CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN | Connecticut Diagnostics, Ltd. | 1979-12-06 | 17 | 0 |
| K791994 | CREATININE DIAG. REAGENT PICRIC ACID | Connecticut Diagnostics, Ltd. | 1979-10-17 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda