Transferrin Rid Kit
FDA 510(k) K914390 · The Binding Site, Ltd.
510(k) numberK914390
Submission
- Device name
- Transferrin Rid Kit
- Applicant
- The Binding Site, Ltd.
Los Angeles, CA, US - Received
- October 1, 1991
- Decision date
- December 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Rid Kit cleared by the FDA?
Transferrin Rid Kit (K914390) received a 510(k) decision of Substantially Equivalent on December 9, 1991, 69 days after the submission was received.
What is the product code of K914390?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.