510(k) K811310
K811310 is an FDA 510(k) premarket notification submitted by Chem-Elec, Inc. for the device "SODIUM/POTASSIUM REAGENT KITS". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code CEM (Electrode, Ion Specific, Potassium), a Class II device regulated under 21 CFR 862.1600. Chem-Elec, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1981
- Date Received
- May 11, 1981
- 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