Corning 614 Na/K Analyzer
FDA 510(k) K843530 · Corning Medical & Scientific
510(k) numberK843530
Submission
- Device name
- Corning 614 Na/K Analyzer
- Applicant
- Corning Medical & Scientific
Medfield, MA, US - Received
- September 7, 1984
- Decision date
- December 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Corning 614 Na/K Analyzer cleared by the FDA?
Corning 614 Na/K Analyzer (K843530) received a 510(k) decision of Substantially Equivalent on December 11, 1984, 95 days after the submission was received.
What is the product code of K843530?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.