The following data is part of a premarket notification filed by Beckman Coulter Biomedical Gmbh with the FDA for Dxa 5000, Dxi 800 Access Immunoassay System, Access Ferritin, Access Folate, Access Tsh (3rd Is), Access Vitamin B12.
| Device ID | K190298 |
| 510k Number | K190298 |
| Device Name: | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munich, DE 81377 |
| Contact | Amanda Brown |
| Correspondent | Amanda Brown Beckman Coulter Biomedical GmbH Sauerbruchstr. 50 Munich, DE 81377 |
| Product Code | CDD |
| Subsequent Product Code | CGN |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JLW |
| Subsequent Product Code | JMG |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-11 |
| Decision Date | 2019-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590707118 | K190298 | 000 |