The following data is part of a premarket notification filed by Beckman Coulter Ireland Inc. with the FDA for Ceruloplasmin.
| Device ID | K161508 |
| 510k Number | K161508 |
| Device Name: | Ceruloplasmin |
| Classification | Ceruloplasmin, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER IRELAND INC. LISMEEHAN O' CALLAGHAN'S, MILLS Co. Clare, IE |
| Contact | Marguerita Sweeney |
| Correspondent | Marguerita Sweeney BECKMAN COULTER IRELAND INC. LISMEEHAN O' CALLAGHAN'S, MILLS Co. Clare, IE |
| Product Code | DDB |
| CFR Regulation Number | 866.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-01 |
| Decision Date | 2017-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590010614 | K161508 | 000 |