The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Total Immunoglobulin E (ige).
| Device ID | K220178 |
| 510k Number | K220178 |
| Device Name: | Total Immunoglobulin E (IgE) |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | Beckman Coulter, Inc. 250 S. Kraemer Boulevard, Mail Stop B1.SE.03 Brea, CA 92821 |
| Contact | Veronica Colinayo |
| Correspondent | Veronica Colinayo Beckman Coulter, Inc. 250 S. Kraemer Boulevard, Mail Stop B1.SE.03 Brea, CA 92821 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-21 |
| Decision Date | 2022-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590701727 | K220178 | 000 |