Ferrizyme Ferritin Enzyme Immunoassay
FDA 510(k) K801676 · Abbott Laboratories
510(k) numberK801676
Submission
- Device name
- Ferrizyme Ferritin Enzyme Immunoassay
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- July 22, 1980
- Decision date
- August 20, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Ferrizyme Ferritin Enzyme Immunoassay cleared by the FDA?
Ferrizyme Ferritin Enzyme Immunoassay (K801676) received a 510(k) decision of Substantially Equivalent on August 20, 1980, 29 days after the submission was received.
What is the product code of K801676?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.