25-Hydroxy Vitamin Ds EIA
FDA 510(k) K142351 · Immunodiagnostic Systems , Ltd.
510(k) numberK142351
Submission
- Device name
- 25-Hydroxy Vitamin Ds EIA
- Applicant
- Immunodiagnostic Systems , Ltd.
Boldon, Tyne & Wear, GB - Received
- August 22, 2014
- Decision date
- August 25, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRG – System, Test, Vitamin D
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1825
- Specialty
- Clinical Chemistry
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Questions and answers
When was 25-Hydroxy Vitamin Ds EIA cleared by the FDA?
25-Hydroxy Vitamin Ds EIA (K142351) received a 510(k) decision of Substantially Equivalent on August 25, 2015, 368 days after the submission was received.
What is the product code of K142351?
The FDA product code is MRG – System, Test, Vitamin D, a Class II (moderate risk) device regulated under 21 CFR 862.1825.