The following data is part of a premarket notification filed by Bio-rad with the FDA for Bio-rad Platelia Toxo Igm Tmb.
| Device ID | K013837 |
| 510k Number | K013837 |
| Device Name: | BIO-RAD PLATELIA TOXO IGM TMB |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | BIO-RAD 6565 185TH AVENUE NE Redmond, WA 98052 |
| Contact | Christopher Bentsen |
| Correspondent | Christopher Bentsen BIO-RAD 6565 185TH AVENUE NE Redmond, WA 98052 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-19 |
| Decision Date | 2002-09-30 |
| Summary: | summary |