Ids-Isys 25-HYDROXY Vitamin D Assay, Ids-Isys 25-HYDROXY Vitamin D Control Set
FDA 510(k) K091849 · Immunodiagnostic Systems, Inc.
510(k) numberK091849
Submission
- Device name
- Ids-Isys 25-HYDROXY Vitamin D Assay, Ids-Isys 25-HYDROXY Vitamin D Control Set
- Applicant
- Immunodiagnostic Systems, Inc.
Fountain Hills, AZ, US - Received
- June 22, 2009
- Decision date
- June 25, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Ids-Isys 25-HYDROXY Vitamin D Assay, Ids-Isys 25-HYDROXY Vitamin D Control Set cleared by the FDA?
Ids-Isys 25-HYDROXY Vitamin D Assay, Ids-Isys 25-HYDROXY Vitamin D Control Set (K091849) received a 510(k) decision of Substantially Equivalent on June 25, 2010, 368 days after the submission was received.
What is the product code of K091849?
The FDA product code is MRG – System, Test, Vitamin D, a Class II (moderate risk) device regulated under 21 CFR 862.1825.