Validate Ferritin Calibration Verification/ Linearity Test Kit
FDA 510(k) K133550 · Maine Standards Company, LLC
510(k) numberK133550
Submission
- Device name
- Validate Ferritin Calibration Verification/ Linearity Test Kit
- Applicant
- Maine Standards Company, LLC
Cumberland Foreside, ME, US - Received
- November 19, 2013
- Decision date
- February 5, 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 Validate Ferritin Calibration Verification/ Linearity Test Kit cleared by the FDA?
Validate Ferritin Calibration Verification/ Linearity Test Kit (K133550) received a 510(k) decision of Substantially Equivalent on February 5, 2014, 78 days after the submission was received.
What is the product code of K133550?
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.