Liberty Glucose Control, Model 2120031
FDA 510(k) K052980 · Liberty Healthcare Group, Inc.
510(k) numberK052980
Submission
- Device name
- Liberty Glucose Control, Model 2120031
- Applicant
- Liberty Healthcare Group, Inc.
Seguin, TX, US - Received
- October 24, 2005
- Decision date
- November 30, 2005
- 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 |
|---|---|---|
| K063855 | Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution…JJX · Traditional | 02/01/2007SE |
| K060706 | Liberty Normal Glucose Control SolutionJJX · Traditional | 04/28/2006SE |
| K060481 | Liberty Glucose Control SolutionJJX · Traditional | 03/09/2006SE |
| K060426 | Liberty Glucose Normal Control Solutions, Model 2120041JJX · Traditional | 03/09/2006SE |
Questions and answers
When was Liberty Glucose Control, Model 2120031 cleared by the FDA?
Liberty Glucose Control, Model 2120031 (K052980) received a 510(k) decision of Substantially Equivalent on November 30, 2005, 37 days after the submission was received.
What is the product code of K052980?
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.