The following data is part of a premarket notification filed by Labsystems, Inc. with the FDA for Toxoplasma Gond Ii Igg Dia Test Kit.
| Device ID | K833829 |
| 510k Number | K833829 |
| Device Name: | TOXOPLASMA GOND II IGG DIA TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | LABSYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-03 |
| Decision Date | 1984-04-24 |