The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxi 800 Access Immunoassay System, Model 973100.
| Device ID | K023764 |
| 510k Number | K023764 |
| Device Name: | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Lynn Weist |
| Correspondent | Lynn Weist BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JJE |
| Subsequent Product Code | CEC |
| Subsequent Product Code | CGR |
| Subsequent Product Code | CHP |
| Subsequent Product Code | JLW |
| Subsequent Product Code | MMI |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-12 |
| Decision Date | 2003-01-28 |
| Summary: | summary |