Ab-Trol and Private Label Glucose Control Solution
FDA 510(k) K080273 · Fujirebio Diagnostics Texas, Inc.
510(k) numberK080273
Submission
- Device name
- Ab-Trol and Private Label Glucose Control Solution
- Applicant
- Fujirebio Diagnostics Texas, Inc.
Seguin, TX, US - Received
- February 1, 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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| K151742 | Contour Next Control SolutionJJX · Traditional | Bayer Healthcare | 09/23/2015SE |
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More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K081915 | FDTX Glucose Control SolutionJJX · Traditional | 08/08/2008SE |
Questions and answers
When was Ab-Trol and Private Label Glucose Control Solution cleared by the FDA?
Ab-Trol and Private Label Glucose Control Solution (K080273) received a 510(k) decision of Substantially Equivalent on August 8, 2008, 189 days after the submission was received.
What is the product code of K080273?
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.