Glucose Oxidase, Glucose
FDA 510(k) K040974 · Genchem, Inc.
510(k) numberK040974
Submission
- Device name
- Glucose Oxidase, Glucose
- Applicant
- Genchem, Inc.
Brea, CA, US - Received
- April 14, 2004
- Decision date
- December 27, 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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| K040976 | Genchem Creatinine ReagentCGX · Traditional | 12/27/2004SE |
| K040975 | Genchem CO2 Acid ReagentJFL · Traditional | 12/27/2004SE |
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Questions and answers
When was Glucose Oxidase, Glucose cleared by the FDA?
Glucose Oxidase, Glucose (K040974) received a 510(k) decision of Substantially Equivalent on December 27, 2004, 257 days after the submission was received.
What is the product code of K040974?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.