Sigma Glucose Reagent
FDA 510(k) K933694 · Sigma Chemical Co.
510(k) numberK933694
Submission
- Device name
- Sigma Glucose Reagent
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- July 29, 1993
- Decision date
- November 4, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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More from Nova Biomedical Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K933678 | Sigma Calcium ReagentCJY · Traditional | 03/11/1994SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
| K933702 | Sigma CX-3 Calibration Standard Level 1JIX · Traditional | 10/08/1993SE |
Questions and answers
When was Sigma Glucose Reagent cleared by the FDA?
Sigma Glucose Reagent (K933694) received a 510(k) decision of Substantially Equivalent on November 4, 1994, 463 days after the submission was received.
What is the product code of K933694?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.