King Diagnostics Glucose Test
FDA 510(k) K811882 · King Diagnostics, Inc.
510(k) numberK811882
Submission
- Device name
- King Diagnostics Glucose Test
- Applicant
- King Diagnostics, Inc.
Mchenry, IL, US - Received
- July 1, 1981
- Decision date
- July 23, 1981
- 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 |
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| K933329 | King Diagnostics Iron and Total Iron Binding Capacity ReagentJMO · Traditional | 10/22/1993SE |
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| K931773 | HDL Precipitating Reagent (Dextran Sulfate)LBR · Traditional | 08/16/1993SE |
| K931326 | King Diagnostics CK ReagentCGS · Traditional | 06/15/1993SE |
| K923129 | King Diagnostics Glucose (HK) ReagentCFR · Traditional | 11/02/1992SE |
| K922969 | King Diagnostics Urea Nitrogen ReagentCDN · Traditional | 10/13/1992SE |
| K922921 | King Diagnostics Chloride ReagentCHJ · Traditional | 10/05/1992SE |
| K923927 | King Diagnostics Magnesium ReagentJGJ · Traditional | 09/30/1992SE |
| K923128 | King Diagnostics Cholesterol ReagentCHH · Traditional | 09/09/1992SE |
| K923091 | King Diagnostics Gamma GT ReagentJPZ · Traditional | 09/09/1992SE |
Questions and answers
When was King Diagnostics Glucose Test cleared by the FDA?
King Diagnostics Glucose Test (K811882) received a 510(k) decision of Substantially Equivalent on July 23, 1981, 22 days after the submission was received.
What is the product code of K811882?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.