The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Centaur Toxoplasma M (toxo M).
| Device ID | K142826 |
| 510k Number | K142826 |
| Device Name: | ADVIA Centaur Toxoplasma M (Toxo M) |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown, NY 10591 |
| Contact | Matthew Gee |
| Correspondent | Matthew Gee SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown, NY 10591 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-12-22 |
| Summary: | summary |