The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access 25(oh) Vitamin D Total For Use On The Access 2 Immuno. Syst., Access 25(oh) Vitamin D Total Calibrators For Use On The Access 2 Immuno. Syst.
| Device ID | K142373 |
| 510k Number | K142373 |
| Device Name: | Access 25(OH) Vitamin D Total For Use On The Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators For Use On The Access 2 Immuno. Syst |
| Classification | System, Test, Vitamin D |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Ryan Severson |
| Correspondent | Ryan Severson BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-25 |
| Decision Date | 2014-12-22 |
| Summary: | summary |