Biotrol Glucose Enzymatique Color Reagent
FDA 510(k) K873117 · Biotrol, USA, Inc.
510(k) numberK873117
Submission
- Device name
- Biotrol Glucose Enzymatique Color Reagent
- Applicant
- Biotrol, USA, Inc.
Berwyn, PA, US - Received
- August 10, 1987
- Decision date
- August 31, 1987
- 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 Biotrol Glucose Enzymatique Color Reagent cleared by the FDA?
Biotrol Glucose Enzymatique Color Reagent (K873117) received a 510(k) decision of Substantially Equivalent on August 31, 1987, 21 days after the submission was received.
What is the product code of K873117?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.