The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Stfr, Access Stfr Calibrators, And Access Stfr Qc With Models, A32493, A32494, And A32495.
| Device ID | K080634 |
| 510k Number | K080634 |
| Device Name: | ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Lynn Weist |
| Correspondent | Lynn Weist BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | DDG |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-06 |
| Decision Date | 2008-08-11 |
| Summary: | summary |