The following data is part of a premarket notification filed by Labsystems, Inc. with the FDA for Modified Labysystems' Toxoplasma Gondii Igg Eia.
| Device ID | K890154 |
| 510k Number | K890154 |
| Device Name: | MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | LABSYSTEMS, INC. PULTTITIE 8 00880 HELSINKI Finland, FI |
| Contact | Paivi Sormunen |
| Correspondent | Paivi Sormunen LABSYSTEMS, INC. PULTTITIE 8 00880 HELSINKI Finland, FI |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-12 |
| Decision Date | 1989-02-07 |