The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Myoglobin On The Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316.
| Device ID | K000196 |
| 510k Number | K000196 |
| Device Name: | ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Jan Olsen |
| Correspondent | Jan Olsen 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 | 2000-01-21 |
| Decision Date | 2000-02-18 |