Easylyte Sodium/Potassium/Lithium Analyzer
FDA 510(k) K914810 · Medica Corp.
510(k) numberK914810
Submission
- Device name
- Easylyte Sodium/Potassium/Lithium Analyzer
- Applicant
- Medica Corp.
Bedford, MA, US - Received
- October 25, 1991
- Decision date
- December 4, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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Questions and answers
When was Easylyte Sodium/Potassium/Lithium Analyzer cleared by the FDA?
Easylyte Sodium/Potassium/Lithium Analyzer (K914810) received a 510(k) decision of Substantially Equivalent on December 4, 1991, 40 days after the submission was received.
What is the product code of K914810?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.