Transferrin
FDA 510(k) K873867 · Unipath , Ltd.
510(k) numberK873867
Submission
- Device name
- Transferrin
- Applicant
- Unipath , Ltd.
Bedford Mk41 Oqg, GB - Received
- August 24, 1987
- Decision date
- October 13, 1987
- 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 Transferrin cleared by the FDA?
Transferrin (K873867) received a 510(k) decision of Substantially Equivalent on October 13, 1987, 50 days after the submission was received.
What is the product code of K873867?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.