Glucose Diagnostic Reagent
FDA 510(k) K801897 · Connecticut Diagnostics, Ltd.
510(k) numberK801897
Submission
- Device name
- Glucose Diagnostic Reagent
- Applicant
- Connecticut Diagnostics, Ltd.
Mchenry, IL, US - Received
- August 8, 1980
- Decision date
- October 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 07/28/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | Instrumentation Laboratory CO | 01/27/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 10/18/2022SE |
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional | Abbott Point of Care, Inc. | 08/13/2021SE |
| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 03/13/2020SE |
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| 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 |
| K792465 | Connecticut Diagnostics, Lts. DirectCIG · Traditional | 12/18/1979SE |
| 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 Glucose Diagnostic Reagent cleared by the FDA?
Glucose Diagnostic Reagent (K801897) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 63 days after the submission was received.
What is the product code of K801897?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.