Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution, Model 2120047
FDA 510(k) K063855 · Liberty Healthcare Group, Inc.
510(k) numberK063855
Submission
- Device name
- Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution, Model 2120047
- Applicant
- Liberty Healthcare Group, Inc.
Seguin, TX, US - Received
- December 28, 2006
- Decision date
- February 1, 2007
- 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 |
|---|---|---|
| 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 |
| K052980 | Liberty Glucose Control, Model 2120031JJX · Traditional | 11/30/2005SE |
Questions and answers
When was Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution, Model 2120047 cleared by the FDA?
Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution, Model 2120047 (K063855) received a 510(k) decision of Substantially Equivalent on February 1, 2007, 35 days after the submission was received.
What is the product code of K063855?
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.