Ultra Blood Glucose Monitoring System
FDA 510(k) K912440 · Home Diagnostics, Inc.
510(k) numberK912440
Submission
- Device name
- Ultra Blood Glucose Monitoring System
- Applicant
- Home Diagnostics, Inc.
Eatontown, NJ, US - Received
- June 3, 1991
- Decision date
- July 17, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was Ultra Blood Glucose Monitoring System cleared by the FDA?
Ultra Blood Glucose Monitoring System (K912440) received a 510(k) decision of Substantially Equivalent on July 17, 1991, 44 days after the submission was received.
What is the product code of K912440?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.