Radias Ferritin Enzyme Immunoassay
FDA 510(k) K933314 · Bio-Rad
510(k) numberK933314
Submission
- Device name
- Radias Ferritin Enzyme Immunoassay
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- July 7, 1993
- Decision date
- September 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DEW – Igg, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Radias Ferritin Enzyme Immunoassay cleared by the FDA?
Radias Ferritin Enzyme Immunoassay (K933314) received a 510(k) decision of Substantially Equivalent on September 8, 1993, 63 days after the submission was received.
What is the product code of K933314?
The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.