Sigma Diagostic Electrolyte Reference Reagent
FDA 510(k) K963542 · Sigma Diagnostics, Inc.
510(k) numberK963542
Submission
- Device name
- Sigma Diagostic Electrolyte Reference Reagent
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- September 4, 1996
- Decision date
- September 27, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Sigma Diagostic Electrolyte Reference Reagent cleared by the FDA?
Sigma Diagostic Electrolyte Reference Reagent (K963542) received a 510(k) decision of Substantially Equivalent on September 27, 1996, 23 days after the submission was received.
What is the product code of K963542?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.