25-HYDROXYVITAMIN D 125I Ria Kit
FDA 510(k) K983617 · DiaSorin, Inc.
510(k) numberK983617
Submission
- Device name
- 25-HYDROXYVITAMIN D 125I Ria Kit
- Applicant
- DiaSorin, Inc.
Columbia, MD, US - Received
- October 15, 1998
- Decision date
- November 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCI – Automated Radioimmunoassay Systems, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
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Questions and answers
When was 25-HYDROXYVITAMIN D 125I Ria Kit cleared by the FDA?
25-HYDROXYVITAMIN D 125I Ria Kit (K983617) received a 510(k) decision of Substantially Equivalent on November 16, 1998, 32 days after the submission was received.
What is the product code of K983617?
The FDA product code is LCI – Automated Radioimmunoassay Systems, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.