Abbott Axsym Folate
FDA 510(k) K972232 · Abbott Laboratories
510(k) numberK972232
Submission
- Device name
- Abbott Axsym Folate
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- June 16, 1997
- Decision date
- June 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Abbott Axsym Folate cleared by the FDA?
Abbott Axsym Folate (K972232) received a 510(k) decision of Substantially Equivalent on June 24, 1997, 8 days after the submission was received.
What is the product code of K972232?
The FDA product code is CGN – Acid, Folic, Radioimmunoassay, a Class II (moderate risk) device regulated under 21 CFR 862.1295.