The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Platelia Toxo Igm Kit Model 26211.
| Device ID | K090847 |
| 510k Number | K090847 |
| Device Name: | PLATELIA TOXO IGM KIT MODEL 26211 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | Bio-Rad Laboratories 6565 185TH AVE, NE Redmond, WA 98052 |
| Contact | Priya Bondre |
| Correspondent | Priya Bondre Bio-Rad Laboratories 6565 185TH AVE, NE Redmond, WA 98052 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-07-01 |