TDX Transferrin Diagnostic Kit
FDA 510(k) K854416 · Abbott Laboratories
510(k) numberK854416
Submission
- Device name
- TDX Transferrin Diagnostic Kit
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- November 4, 1985
- Decision date
- February 21, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
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Questions and answers
When was TDX Transferrin Diagnostic Kit cleared by the FDA?
TDX Transferrin Diagnostic Kit (K854416) received a 510(k) decision of Substantially Equivalent on February 21, 1986, 109 days after the submission was received.
What is the product code of K854416?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.