FDTX Glucose Control Solution
FDA 510(k) K081915 · Fujirebio Diagnostics Texas, Inc.
510(k) numberK081915
Submission
- Device name
- FDTX Glucose Control Solution
- Applicant
- Fujirebio Diagnostics Texas, Inc.
Seguin, TX, US - Received
- July 3, 2008
- Decision date
- August 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K080273 | Ab-Trol and Private Label Glucose Control SolutionJJX · Traditional | 08/08/2008SE |
Questions and answers
When was FDTX Glucose Control Solution cleared by the FDA?
FDTX Glucose Control Solution (K081915) received a 510(k) decision of Substantially Equivalent on August 8, 2008, 36 days after the submission was received.
What is the product code of K081915?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.