510(k) K201396
K201396 is an FDA 510(k) premarket notification submitted by Osang Healthcare Co. , Ltd. for the device "Finetest Lite Smart Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on Oct 16, 2020. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Osang Healthcare Co. , Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 2020
- Date Received
- May 28, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Blood Glucose, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type
- 510(k)