510(k) K896316
K896316 is an FDA 510(k) premarket notification submitted by Eos Technology Corp. for the device "EOS IONIZED CALCIUM TEST CARD". The FDA issued a decision of Substantially Equivalent on February 13, 1990. The device falls under product code JFP (Electrode, Ion Specific, Calcium), a Class II device regulated under 21 CFR 862.1145. Eos Technology Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1990
- Date Received
- November 1, 1989
- 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