Fdtx Glucose Control Solution
by Fujirebio Diagnostics Texas, Inc.
510(k) K081915
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 | NumberK081915 | Date8 Aug 2008 | StatusActive |
Official records
- FDA 510(k) database K081915
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JJX
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1660
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 9 Nov 2026
The device is a Single (Specified) Analyte Controls (Assayed And Unassayed).
It was cleared by the FDA via 510(k) K081915 on 2008-08-08.
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