The following data is part of a premarket notification filed by Bio-rad with the FDA for Platelia Aspergillus Eia, Models 62793 And 62794.
| Device ID | K023857 |
| 510k Number | K023857 |
| Device Name: | PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 |
| Classification | Antigen, Galactomannan, Aspergillus Spp. |
| Applicant | BIO-RAD CLINICAL DIAGNOSTICS GROUP 6565 185TH AVENUE NE Redmond, WA 98052 |
| Contact | Christopher Bentsen |
| Correspondent | Christopher Bentsen BIO-RAD CLINICAL DIAGNOSTICS GROUP 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 | 2002-11-20 |
| Decision Date | 2003-05-16 |
| Summary: | summary |