510(k) K860639
K860639 is an FDA 510(k) premarket notification submitted by Ilex Corp. for the device "IONIZED CALCIUM AND BLOOD PH TESTCARDS". The FDA issued a decision of Substantially Equivalent on April 21, 1986. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Ilex Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1986
- Date Received
- February 20, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Calcium
- Device Class
- Class II
- Regulation Number
- 862.1145
- Review Panel
- CH
- Submission Type