Go/Hpo-Glucose Reagent (Trinder)
FDA 510(k) K770200 · Beckman Instruments, Inc.
510(k) numberK770200
Submission
- Device name
- Go/Hpo-Glucose Reagent (Trinder)
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- January 31, 1977
- Decision date
- February 23, 1977
- 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 Go/Hpo-Glucose Reagent (Trinder) cleared by the FDA?
Go/Hpo-Glucose Reagent (Trinder) (K770200) received a 510(k) decision of Substantially Equivalent on February 23, 1977, 23 days after the submission was received.
What is the product code of K770200?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.