The following data is part of a premarket notification filed by Labsystems, Inc. with the FDA for Modified Toxoplasma Gondii Igg Eia Test Kit.
| Device ID | K872252 |
| 510k Number | K872252 |
| Device Name: | MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | LABSYSTEMS, INC. 6200 W. OAKTON Morton Grove, IL 60053 |
| Contact | Nancy Skowronski |
| Correspondent | Nancy Skowronski 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 | 1987-06-11 |
| Decision Date | 1987-07-01 |