510(k) K896692
K896692 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER". The FDA issued a decision of Substantially Equivalent on Jan 2, 1990. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 2, 1990
- Date Received
- Nov 28, 1989
- 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
- 510(k)