Connecticut Diagnostics, Ltd.
Mchenry, IL, US
Connecticut Diagnostics, Ltd. appears in FDA device records in Mchenry, IL. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Connecticut Diagnostics, Ltd. between 1979 and 1991. The busiest year on record is 1979, with 7. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 7 |
| 1980 | 2 |
| 1981 | 1 |
| 1982 | 3 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K905617 | VISI-STAPH | JWX | Substantially Equivalent | |
| K822504 | CDL AUTO-LYSING REAGENT | GGK | Substantially Equivalent | |
| K822501 | CDL ISOTONIC DILUENT | GIF | Substantially Equivalent | |
| K822500 | CDL LYSING REAGENT | GGK | Substantially Equivalent | |
| K811222 | INORGANIC PHOSPHORUS REAGENTS | CED | Substantially Equivalent | |
| K801898 | URIC ACID DIAGNOSTIC REAGENT | KNK | Substantially Equivalent | |
| K801897 | GLUCOSE DIAGNOSTIC REAGENT | CGA | Substantially Equivalent | |
| K792465 | CONNECTICUT DIAGNOSTICS, LTS. DIRECT | CIG | Substantially Equivalent | |
| K792362 | BLOOD UREA NITROGEN REAGENT | JGZ | Substantially Equivalent | |
| K792340 | CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE | CEK | Substantially Equivalent | |
| K792339 | CONNECT. DIAG. ALBUMIN DIAGNOSTIC REAGEN | CIX | Substantially Equivalent | |
| K792338 | DONNECT. DIAG. TOTAL BILIRUBIN REAGENTS | CIG | Substantially Equivalent | |
| K792337 | DONNECT. DIAG. CALCIUM DIAG. REAGENT | CIC | Substantially Equivalent | |
| K791994 | CREATININE DIAG. REAGENT PICRIC ACID | CGX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CED5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- GIFDiluent, Blood Cell
- CGAGlucose Oxidase, Glucose
- JWXKit, Screening, Staphylococcus Aureus
- JGZO-Phthalaldehyde, Urea Nitrogen
- GGKProducts, Red-Cell Lysing Products
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain