Mpx System, Glucose Test System
510(k) K864322
Mpx System, Glucose Test System is a Class II device made by Lifescan, Inc., cleared under FDA 510(k) K864322 on 25 Feb 1987, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864322 | Date25 Feb 1987 | StatusActive |
Official records
- FDA 510(k) database K864322
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CGA
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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