CamAPS FX
by CamDiab
510(k) K232603
CamAPS FX is a Class II device made by CamDiab, cleared under FDA 510(k) K232603 on 23 May 2024, 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 | NumberK232603 | Date23 May 2024 | StatusActive |
Official records
- FDA 510(k) database K232603
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QJI
- FDA applicant
- Camdiab , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1356
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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