Ektachem Clinical Chemistry Slide Sodium (Na+)
FDA 510(k) K961099 · Johnson & Johnson Clinical Diagnostics, Inc.
510(k) numberK961099
Submission
- Device name
- Ektachem Clinical Chemistry Slide Sodium (Na+)
- Applicant
- Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- March 19, 1996
- Decision date
- May 7, 1996
- 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 Ektachem Clinical Chemistry Slide Sodium (Na+) cleared by the FDA?
Ektachem Clinical Chemistry Slide Sodium (Na+) (K961099) received a 510(k) decision of Substantially Equivalent on May 7, 1996, 49 days after the submission was received.
What is the product code of K961099?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.