510(k) K970330
K970330 is an FDA 510(k) premarket notification submitted by Dade Intl., Inc. for the device "DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE". The FDA issued a decision of Substantially Equivalent on April 14, 1997. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Dade Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1997
- Date Received
- January 28, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Potassium
- Device Class
- Class II
- Regulation Number
- 862.1600
- Review Panel
- CH
- Submission Type