The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Immunoassay Systems Myoglobin And Access Immunoassay Systems Myoglobin Calibrators.
| Device ID | K080481 |
| 510k Number | K080481 |
| Device Name: | ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Chechamma Varughese |
| Correspondent | Chechamma Varughese 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 | 2008-02-22 |
| Decision Date | 2009-02-20 |
| Summary: | summary |