510(k) K853068
K853068 is an FDA 510(k) premarket notification submitted by Ilex Corp. for the device "ILEX PROMPT CLINICAL CHEMISTRY ANALYER". The FDA issued a decision of Substantially Equivalent on October 31, 1985. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Ilex Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1985
- Date Received
- July 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