The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Toxo-cube.
| Device ID | K903968 |
| 510k Number | K903968 |
| Device Name: | TOXO-CUBE |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104 |
| Contact | Walter Fischer |
| Correspondent | Walter Fischer DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1990-12-18 |