510(k) K180186
K180186 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 August 23, 2018. 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
- August 23, 2018
- Date Received
- January 23, 2018
- 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