The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Toxo Igg Assay On The Access Immunoassay System.
| Device ID | K951495 |
| 510k Number | K951495 |
| Device Name: | ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Carole Stamp |
| Correspondent | Carole Stamp BIO-RAD LABORATORIES, 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 | 1995-03-31 |
| Decision Date | 1995-12-20 |