The following data is part of a premarket notification filed by Bio-rad with the FDA for Platelia Aspergillus Eia, Model 62793.
Device ID | K060641 |
510k Number | K060641 |
Device Name: | PLATELIA ASPERGILLUS EIA, MODEL 62793 |
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 | 2006-03-10 |
Decision Date | 2006-06-02 |
Summary: | summary |