510(k) K801795
K801795 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 1980
- Date Received
- July 29, 1980
- 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