The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Immunoassay System Toxo Igm Ii Assay.
| Device ID | K031506 |
| 510k Number | K031506 |
| Device Name: | ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| 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 | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-14 |
| Decision Date | 2003-06-02 |
| Summary: | summary |