The following data is part of a premarket notification filed by Beckman Coulter Ireland Inc. with the FDA for Urine/csf Albumin, Urine/csf Albumin Calibrator.
| Device ID | K142346 |
| 510k Number | K142346 |
| Device Name: | Urine/CSF Albumin, Urine/CSF Albumin Calibrator |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | Beckman Coulter Ireland Inc. Lismeehan, O'Callaghan's Mills Co. Clare, IE |
| Contact | Anne-marie Shine |
| Correspondent | Anne-marie Shine Beckman Coulter Ireland Inc. Lismeehan, O'Callaghan's Mills Co. Clare, IE |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-22 |
| Decision Date | 2014-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590670108 | K142346 | 000 |
| 15099590666361 | K142346 | 000 |
| 15099590020422 | K142346 | 000 |