Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model# KT-0105-A,CA-0105-A,B,C
FDA 510(k) K063766 · Good Biotech Corp.
510(k) numberK063766
Submission
- Device name
- Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model# KT-0105-A,CA-0105-A,B,C
- Applicant
- Good Biotech Corp.
Taichung, TW - Received
- December 20, 2006
- Decision date
- April 23, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Tia , Calibrator Set, Control-L,Control-M,Control-H, Model# KT-0105-A,CA-0105-A,B,C cleared by the FDA?
Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model# KT-0105-A,CA-0105-A,B,C (K063766) received a 510(k) decision of Substantially Equivalent on April 23, 2007, 124 days after the submission was received.
What is the product code of K063766?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.