Sigma Diagnostics Glucose Reagent
FDA 510(k) K963535 · Sigma Diagnostics, Inc.
510(k) numberK963535
Submission
- Device name
- Sigma Diagnostics Glucose Reagent
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- September 4, 1996
- Decision date
- January 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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Questions and answers
When was Sigma Diagnostics Glucose Reagent cleared by the FDA?
Sigma Diagnostics Glucose Reagent (K963535) received a 510(k) decision of Substantially Equivalent on January 17, 1997, 135 days after the submission was received.
What is the product code of K963535?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.