510(k) K192987
K192987 is an FDA 510(k) premarket notification submitted by Jana Care, Inc. for the device "Aina HbA1c Monitoring System 2". The FDA issued a decision of Substantially Equivalent on March 26, 2020. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2020
- Date Received
- October 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Glycosylated Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7470
- Review Panel
- HE
- Submission Type