The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Toxoplasma Gondii Igg.
| Device ID | K950671 |
| 510k Number | K950671 |
| Device Name: | IMMULITE TOXOPLASMA GONDII IGG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Kenneth Asarch |
| Correspondent | Kenneth Asarch DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-13 |
| Decision Date | 1996-02-23 |