Cholestech Lipid Monitoring System, Glucose Test
FDA 510(k) K904082 · Cholestech Corp.
510(k) numberK904082
Submission
- Device name
- Cholestech Lipid Monitoring System, Glucose Test
- Applicant
- Cholestech Corp.
Hayward, CA, US - Received
- September 5, 1990
- Decision date
- December 26, 1990
- 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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| K946066 | Total Cholesterol, HDL Cholesterol and Glucose PanelCHH · Traditional | 02/22/1995SE |
| K946065 | Total Cholesterolm HDL Cholesterol and Triglycerides PanelCHH · Traditional | 02/22/1995SE |
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Questions and answers
When was Cholestech Lipid Monitoring System, Glucose Test cleared by the FDA?
Cholestech Lipid Monitoring System, Glucose Test (K904082) received a 510(k) decision of Substantially Equivalent on December 26, 1990, 112 days after the submission was received.
What is the product code of K904082?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.