510(k) K200349
K200349 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corporation for the device "Stat Profile Prime Plus Analyzer System". The FDA issued a decision of Substantially Equivalent on March 13, 2020. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Nova Biomedical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2020
- Date Received
- February 12, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type