510(k) K853356
K853356 is an FDA 510(k) premarket notification submitted by Horiba Instruments, Inc. for the device "SERA-210 ELECTROLYTE ANALYZER". The FDA issued a decision of Substantially Equivalent on September 3, 1985. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Horiba Instruments, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1985
- Date Received
- August 12, 1985
- 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