Glucosite Test System
FDA 510(k) K971145 · Gds Technology, LLC
510(k) numberK971145
Submission
- Device name
- Glucosite Test System
- Applicant
- Gds Technology, LLC
Elkhart, IN, US - Received
- March 28, 1997
- Decision date
- September 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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| K992132 | Cholesite Test SystemCHH · Traditional | 08/20/1999SE |
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Questions and answers
When was Glucosite Test System cleared by the FDA?
Glucosite Test System (K971145) received a 510(k) decision of Substantially Equivalent on September 17, 1997, 173 days after the submission was received.
What is the product code of K971145?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.