The following data is part of a premarket notification filed by M.a. Bioproducts with the FDA for Toxoelisa Test Kit.
| Device ID | K813221 |
| 510k Number | K813221 |
| Device Name: | TOXOELISA TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | M.A. BIOPRODUCTS 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 | 1981-11-09 |
| Decision Date | 1982-01-26 |