The following data is part of a premarket notification filed by Labsystems, Inc. with the FDA for Toxoplasma Gondii Igm Eia Test Kit.
| Device ID | K842797 |
| 510k Number | K842797 |
| Device Name: | TOXOPLASMA GONDII IGM EIA TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | LABSYSTEMS, INC. P.O. BOX 48723 Chicago , IL 60648 - |
| Contact | Casey P Eitner |
| Correspondent | Casey P Eitner LABSYSTEMS, INC. P.O. BOX 48723 Chicago , IL 60648 - |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-17 |
| Decision Date | 1984-10-17 |