The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Toxo Igg.
| Device ID | K210596 |
| 510k Number | K210596 |
| Device Name: | ARCHITECT Toxo IgG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | Abbott Laboratories Dept 09AA, Bldg. Ap8-1, 100 Abbott Park Rd. Abbott Park, IL 60064 |
| Contact | Linda Sohn |
| Correspondent | Linda Sohn Abbott Laboratories Dept 09AA, Bldg. Ap8-1, 100 Abbott Park Rd. Abbott Park, IL 60064 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-01 |
| Decision Date | 2022-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740203177 | K210596 | 000 |
| 00380740174361 | K210596 | 000 |
| 00380740174354 | K210596 | 000 |
| 00380740174347 | K210596 | 000 |