In-Vitro Test for the Determination of Glucose
FDA 510(k) K854177 · Clinical Data, Inc.
510(k) numberK854177
Submission
- Device name
- In-Vitro Test for the Determination of Glucose
- Applicant
- Clinical Data, Inc.
Boston, MA, US - Received
- October 15, 1985
- Decision date
- November 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 In-Vitro Test for the Determination of Glucose cleared by the FDA?
In-Vitro Test for the Determination of Glucose (K854177) received a 510(k) decision of Substantially Equivalent on November 25, 1985, 41 days after the submission was received.
What is the product code of K854177?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.