510(k) K061830
K061830 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+". The FDA issued a decision of Substantially Equivalent on November 1, 2006. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2006
- Date Received
- June 28, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diazo Colorimetry, Bilirubin
- Device Class
- Class II
- Regulation Number
- 862.1110
- Review Panel
- CH
- Submission Type