The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Toxo Igg, Access Toxo Igg Calibrators And Access Toxo Igg Qc.
| Device ID | K080869 |
| 510k Number | K080869 |
| Device Name: | ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | David M Ikeda |
| Correspondent | David M Ikeda BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-05-23 |
| Summary: | summary |