Fujirebio Diagnostics Vitamin D Control
FDA 510(k) K110641 · Fujirebio Diagnostics,Inc.
510(k) numberK110641
Submission
- Device name
- Fujirebio Diagnostics Vitamin D Control
- Applicant
- Fujirebio Diagnostics,Inc.
Seguin, TX, US - Received
- March 4, 2011
- Decision date
- May 27, 2011
- 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 Fujirebio Diagnostics Vitamin D Control cleared by the FDA?
Fujirebio Diagnostics Vitamin D Control (K110641) received a 510(k) decision of Substantially Equivalent on May 27, 2011, 84 days after the submission was received.
What is the product code of K110641?
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.