The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Immunoassay Systems Br Monitor, And Calibrators, Model(s) 387620,and 387647.
| Device ID | K072612 |
| 510k Number | K072612 |
| Device Name: | ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 |
| Classification | System, Test, Immunological, Antigen, Tumor |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Rachelle Parsons |
| Correspondent | Rachelle Parsons BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-17 |
| Decision Date | 2007-10-26 |
| Summary: | summary |