Vista Ferritin Assay
FDA 510(k) K931576 · Syva Co.
510(k) numberK931576
Submission
- Device name
- Vista Ferritin Assay
- Applicant
- Syva Co.
San Jose, CA, US - Received
- March 30, 1993
- Decision date
- August 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DBF – Ferritin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
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Questions and answers
When was Vista Ferritin Assay cleared by the FDA?
Vista Ferritin Assay (K931576) received a 510(k) decision of Substantially Equivalent on August 5, 1993, 128 days after the submission was received.
What is the product code of K931576?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.