510(k) K192957
K192957 is an FDA 510(k) premarket notification submitted by Vivachek Biotech (Hangzhou) Co., Ltd. for the device "VivaChek Blood Glucose and B-Ketone Monitoring System". The FDA issued a decision of Substantially Equivalent on June 5, 2020. The device falls under product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1435. Vivachek Biotech (Hangzhou) Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2020
- Date Received
- October 21, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nitroprusside, Ketones (Urinary, Non-Quant.)
- Device Class
- Class I
- Regulation Number
- 862.1435
- Review Panel
- CH
- Submission Type