510(k) K200204
K200204 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 April 6, 2020. The device falls under product code GGZ (Oxyhemoglobin), a Class II device regulated under 21 CFR 864.7500. Nova Biomedical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 2020
- Date Received
- January 28, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oxyhemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7500
- Review Panel
- HE
- Submission Type