Connecticut Diagnostics, Lts. Direct
FDA 510(k) K792465 · Connecticut Diagnostics, Ltd.
510(k) numberK792465
Submission
- Device name
- Connecticut Diagnostics, Lts. Direct
- Applicant
- Connecticut Diagnostics, Ltd.
Mchenry, IL, US - Received
- December 3, 1979
- Decision date
- December 18, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIG – Diazo Colorimetry, Bilirubin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1110
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/27/2026SE |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/12/2023SE |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil)CIG · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/20/2023SE |
| K223324 | Total Bilirubin2CIG · Traditional | Abbott Ireland Diagnostics Division | 12/29/2022SE |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP SlidesCIG · Traditional | Ortho-Clinical Diagnostics, Inc. | 04/26/2019SE |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…CIG · Traditional | Elitechgroup | 07/11/2017SE |
| K150510 | Total BilirubinCIG · Traditional | Abbott Laboratories | 04/02/2015SE |
| K131544 | Cobas C Bilirubin Total GEN.3CIG · Traditional | Roche Diagnostics | 07/17/2013SE |
| K131217 | S Test Reagent Cartridge Total BilirubinCIG · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K123802 | Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentCIG · Traditional | Medica Corp. | 03/01/2013SE |
More from Medica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K905617 | Visi-StaphJWX · Traditional | 03/29/1991SE |
| K822504 | CDL Auto-Lysing ReagentGGK · Traditional | 09/17/1982SE |
| K822501 | CDL Isotonic DiluentGIF · Traditional | 09/17/1982SE |
| K822500 | CDL Lysing ReagentGGK · Traditional | 09/17/1982SE |
| K811222 | Inorganic Phosphorus ReagentsCED · Traditional | 05/21/1981SE |
| K801898 | Uric Acid Diagnostic ReagentKNK · Traditional | 10/10/1980SE |
| K801897 | Glucose Diagnostic ReagentCGA · Traditional | 10/10/1980SE |
| K792362 | Blood Urea Nitrogen ReagentJGZ · Traditional | 12/06/1979SE |
| K792340 | Connect. Diag. Total Protein Diag. ReageCEK · Traditional | 12/06/1979SE |
| K792339 | Connect. Diag. Albumin Diagnostic ReagenCIX · Traditional | 12/06/1979SE |
Questions and answers
When was Connecticut Diagnostics, Lts. Direct cleared by the FDA?
Connecticut Diagnostics, Lts. Direct (K792465) received a 510(k) decision of Substantially Equivalent on December 18, 1979, 15 days after the submission was received.
What is the product code of K792465?
The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.