MPX System, Glucose Test System
FDA 510(k) K864322 · Lifescan, Inc.
510(k) numberK864322
Submission
- Device name
- MPX System, Glucose Test System
- Applicant
- Lifescan, Inc.
Mountain View, CA, US - Received
- November 3, 1986
- Decision date
- February 25, 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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| K072543 | Onetouch Select Blood Glucose Monitoring SystemNBW · Special | 10/05/2007SE |
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Questions and answers
When was MPX System, Glucose Test System cleared by the FDA?
MPX System, Glucose Test System (K864322) received a 510(k) decision of Substantially Equivalent on February 25, 1987, 114 days after the submission was received.
What is the product code of K864322?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.