Clover A1C/GLYCOSYLATED Hemoglobin Monitor & Blood Glucose Monitor, Model IGM-0023
FDA 510(k) K082275 · Infopia Co, Ltd.
510(k) numberK082275
Submission
- Device name
- Clover A1C/GLYCOSYLATED Hemoglobin Monitor & Blood Glucose Monitor, Model IGM-0023
- Applicant
- Infopia Co, Ltd.
Great Neck, NY, US - Received
- August 11, 2008
- Decision date
- January 14, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
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| K132406 | Elementv Blood Glucose Monitoring SystemNBW · Traditional | 04/18/2014SE |
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| K132966 | Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring…NBW · Traditional | 12/05/2013SE |
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Questions and answers
When was Clover A1C/GLYCOSYLATED Hemoglobin Monitor & Blood Glucose Monitor, Model IGM-0023 cleared by the FDA?
Clover A1C/GLYCOSYLATED Hemoglobin Monitor & Blood Glucose Monitor, Model IGM-0023 (K082275) received a 510(k) decision of Substantially Equivalent on January 14, 2010, 521 days after the submission was received.
What is the product code of K082275?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.