510(k) K854723
K854723 is an FDA 510(k) premarket notification submitted by Smithkline Diagnostics, Inc. for the device "SKD ELECTROCHEMICAL SYSTEM (ECS)". The FDA issued a decision of Substantially Equivalent on March 5, 1986. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Smithkline Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1986
- Date Received
- November 22, 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