Diazyme 25-HYDROXY Vitamin D Eia Kit Diazyme 25-HYDROXY Vitamin D Eia Control Set Dia
FDA 510(k) K122420 · Diazyme Laboratories
510(k) numberK122420
Submission
- Device name
- Diazyme 25-HYDROXY Vitamin D Eia Kit Diazyme 25-HYDROXY Vitamin D Eia Control Set Dia
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- August 9, 2012
- Decision date
- November 28, 2012
- 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 Diazyme 25-HYDROXY Vitamin D Eia Kit Diazyme 25-HYDROXY Vitamin D Eia Control Set Dia cleared by the FDA?
Diazyme 25-HYDROXY Vitamin D Eia Kit Diazyme 25-HYDROXY Vitamin D Eia Control Set Dia (K122420) received a 510(k) decision of Substantially Equivalent on November 28, 2012, 111 days after the submission was received.
What is the product code of K122420?
The FDA product code is MRG – System, Test, Vitamin D, a Class II (moderate risk) device regulated under 21 CFR 862.1825.