The following data is part of a premarket notification filed by Pharmacia Diagnostics, Inc. with the FDA for Toxoplasma Gondii Igg.
| Device ID | K902792 |
| 510k Number | K902792 |
| Device Name: | TOXOPLASMA GONDII IGG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | PHARMACIA DIAGNOSTICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Contact | Karen Darcy |
| Correspondent | Karen Darcy PHARMACIA DIAGNOSTICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-26 |
| Decision Date | 1990-07-24 |