The following data is part of a premarket notification filed by Bio-rad with the FDA for Platelia Aspergillus Eia Model 62793.
| Device ID | K093678 |
| 510k Number | K093678 |
| Device Name: | PLATELIA ASPERGILLUS EIA MODEL 62793 |
| Classification | Antigen, Galactomannan, Aspergillus Spp. |
| 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 | NOM |
| CFR Regulation Number | 866.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-27 |
| Decision Date | 2011-01-13 |
| Summary: | summary |