Quantia IgE
FDA 510(k) K214068 · Biokit, S.A.
510(k) numberK214068
Submission
- Device name
- Quantia IgE
- Applicant
- Biokit, S.A.
Lliçà D´Amunt, ES - Received
- December 27, 2021
- Decision date
- February 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Quantia IgE cleared by the FDA?
Quantia IgE (K214068) received a 510(k) decision of Substantially Equivalent on February 21, 2023, 421 days after the submission was received.
What is the product code of K214068?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.