Transferrin Kit for Use on the Spaplus
FDA 510(k) K120236 · The Binding Site Group , Ltd.
510(k) numberK120236
Submission
- Device name
- Transferrin Kit for Use on the Spaplus
- Applicant
- The Binding Site Group , Ltd.
Birmingham, GB - Received
- January 26, 2012
- Decision date
- February 13, 2013
- 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 Kit for Use on the Spaplus cleared by the FDA?
Transferrin Kit for Use on the Spaplus (K120236) received a 510(k) decision of Substantially Equivalent on February 13, 2013, 384 days after the submission was received.
What is the product code of K120236?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.