The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Myoglobin And Myoglobin Calibrators On The Access Immunoassay Systems, Model 973243, 973244.
| Device ID | K021229 |
| 510k Number | K021229 |
| Device Name: | MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-18 |
| Decision Date | 2002-06-28 |
| Summary: | summary |