Fdi Level I and Level II Glucose Controls for the Embrace No Code
FDA 510(k) K133197 · Fujirebio Diagnostics,Inc.
510(k) numberK133197
Submission
- Device name
- Fdi Level I and Level II Glucose Controls for the Embrace No Code
- Applicant
- Fujirebio Diagnostics,Inc.
Seguin, TX, US - Received
- October 17, 2013
- Decision date
- January 17, 2014
- 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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Questions and answers
When was Fdi Level I and Level II Glucose Controls for the Embrace No Code cleared by the FDA?
Fdi Level I and Level II Glucose Controls for the Embrace No Code (K133197) received a 510(k) decision of Substantially Equivalent on January 17, 2014, 92 days after the submission was received.
What is the product code of K133197?
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.