510(k) K220178
K220178 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Total Immunoglobulin E (IgE)". The FDA issued a decision of Substantially Equivalent on March 23, 2022. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2022
- Date Received
- January 21, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ige, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type