510(k) K001761
K001761 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corp. for the device "STATLYTE NA/K/CL/LI ANALYZER". The FDA issued a decision of Substantially Equivalent on August 7, 2000. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Nova Biomedical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2000
- Date Received
- June 9, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Sodium
- Device Class
- Class II
- Regulation Number
- 862.1665
- Review Panel
- CH
- Submission Type