Glucose Reagent for Beckman Synchron CX & CX Delta Systems
FDA 510(k) K033055 · Diamond Diagnostics, Inc.
510(k) numberK033055
Submission
- Device name
- Glucose Reagent for Beckman Synchron CX & CX Delta Systems
- Applicant
- Diamond Diagnostics, Inc.
Holliston, MA, US - Received
- September 29, 2003
- Decision date
- January 30, 2004
- 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 Glucose Reagent for Beckman Synchron CX & CX Delta Systems cleared by the FDA?
Glucose Reagent for Beckman Synchron CX & CX Delta Systems (K033055) received a 510(k) decision of Substantially Equivalent on January 30, 2004, 123 days after the submission was received.
What is the product code of K033055?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.