The following data is part of a premarket notification filed by Amico Lab, Inc. with the FDA for Amizyme-toxoplasma Gondii Kit.
| Device ID | K842528 |
| 510k Number | K842528 |
| Device Name: | AMIZYME-TOXOPLASMA GONDII KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | AMICO LAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-28 |
| Decision Date | 1984-09-07 |