One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose Monitoring System
FDA 510(k) K011479 · Inverness Medical Innovations, Inc.
510(k) numberK011479
Submission
- Device name
- One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose Monitoring System
- Applicant
- Inverness Medical Innovations, Inc.
Waltham, MA, US - Received
- May 14, 2001
- Decision date
- November 30, 2001
- 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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Questions and answers
When was One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose Monitoring System cleared by the FDA?
One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose Monitoring System (K011479) received a 510(k) decision of Substantially Equivalent on November 30, 2001, 200 days after the submission was received.
What is the product code of K011479?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.