The following data is part of a premarket notification filed by Labsystems, Inc. with the FDA for Toxoplasma Gondii Igg Eia Test Kit (amendment).
| Device ID | K862216 |
| 510k Number | K862216 |
| Device Name: | TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | LABSYSTEMS, INC. 6200 W. OAKTON Morton Grove, IL 60053 |
| Contact | Labsystems, Inc. |
| Correspondent | Labsystems, Inc. LABSYSTEMS, INC. 6200 W. OAKTON Morton Grove, IL 60053 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-10 |
| Decision Date | 1986-06-30 |