510(k) K864862
K864862 is an FDA 510(k) premarket notification submitted by Hf Scientific, Inc. for the device "REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.". The FDA issued a decision of Substantially Equivalent on February 20, 1987. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Hf Scientific, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 1987
- Date Received
- December 11, 1986
- 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