Radias Red Cell Folate Immunoasay
FDA 510(k) K944212 · Bio-Rad
510(k) numberK944212
Submission
- Device name
- Radias Red Cell Folate Immunoasay
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- August 29, 1994
- Decision date
- February 3, 1995
- 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 Red Cell Folate Immunoasay cleared by the FDA?
Radias Red Cell Folate Immunoasay (K944212) received a 510(k) decision of Substantially Equivalent on February 3, 1995, 158 days after the submission was received.
What is the product code of K944212?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.