510(k) K981425
K981425 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS". The FDA issued a decision of Substantially Equivalent on May 12, 1998. The device falls under product code GKF (Instrument, Hematocrit, Automated), a Class II device regulated under 21 CFR 864.5600. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 1998
- Date Received
- April 16, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Hematocrit, Automated
- Device Class
- Class II
- Regulation Number
- 864.5600
- Review Panel
- HE
- Submission Type