Visual Blood Glucose Test System
FDA 510(k) K884993 · Diagnostic Systems
510(k) numberK884993
Submission
- Device name
- Visual Blood Glucose Test System
- Applicant
- Diagnostic Systems
Rock Hill, SC, US - Received
- December 1, 1988
- Decision date
- December 29, 1988
- 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 Visual Blood Glucose Test System cleared by the FDA?
Visual Blood Glucose Test System (K884993) received a 510(k) decision of Substantially Equivalent on December 29, 1988, 28 days after the submission was received.
What is the product code of K884993?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.