The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Br Monitor And Br Monitor Calibrators On The Access Immunoassay Systems, Model 387620, 387647.
| Device ID | K033036 |
| 510k Number | K033036 |
| Device Name: | BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 |
| Classification | System, Test, Immunological, Antigen, Tumor |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Brent Taber |
| Correspondent | Brent Taber BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-02-03 |
| Summary: | summary |