Easyplus Self Monitoring Glucose Test System, Model EPS04014
FDA 510(k) K061992 · Eps Bio Technology Corp.
510(k) numberK061992
Submission
- Device name
- Easyplus Self Monitoring Glucose Test System, Model EPS04014
- Applicant
- Eps Bio Technology Corp.
Hsinchu City, TW - Received
- July 13, 2006
- Decision date
- September 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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Questions and answers
When was Easyplus Self Monitoring Glucose Test System, Model EPS04014 cleared by the FDA?
Easyplus Self Monitoring Glucose Test System, Model EPS04014 (K061992) received a 510(k) decision of Substantially Equivalent on September 19, 2006, 68 days after the submission was received.
What is the product code of K061992?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.