ADVIA Centaur Total IgE (tIgE)
FDA 510(k) K193493 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK193493
Submission
- Device name
- ADVIA Centaur Total IgE (tIgE)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- December 17, 2019
- Decision date
- January 15, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 ADVIA Centaur Total IgE (tIgE) cleared by the FDA?
ADVIA Centaur Total IgE (tIgE) (K193493) received a 510(k) decision of Substantially Equivalent on January 15, 2020, 29 days after the submission was received.
What is the product code of K193493?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.