The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Immunoassay System Rubella Igg Assay.
| Device ID | K031606 |
| 510k Number | K031606 |
| Device Name: | ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| 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 | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-22 |
| Decision Date | 2003-06-20 |
| Summary: | summary |