Radias Folate Enzyme Immunoassay
FDA 510(k) K933571 · Bio-Rad
510(k) numberK933571
Submission
- Device name
- Radias Folate Enzyme Immunoassay
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- July 23, 1993
- Decision date
- October 1, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGN – Acid, Folic, Radioimmunoassay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1295
- Specialty
- Clinical Chemistry
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Questions and answers
When was Radias Folate Enzyme Immunoassay cleared by the FDA?
Radias Folate Enzyme Immunoassay (K933571) received a 510(k) decision of Substantially Equivalent on October 1, 1993, 70 days after the submission was received.
What is the product code of K933571?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.