Total Immunoglobulin E (IgE)
FDA 510(k) K220178 · Beckman Coulter, Inc.
510(k) numberK220178
Submission
- Device name
- Total Immunoglobulin E (IgE)
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- January 21, 2022
- Decision date
- March 23, 2022
- 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 Total Immunoglobulin E (IgE) cleared by the FDA?
Total Immunoglobulin E (IgE) (K220178) received a 510(k) decision of Substantially Equivalent on March 23, 2022, 61 days after the submission was received.
What is the product code of K220178?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.