Panels › Microbiology › Product code NOM · Class 1
Antigen, Galactomannan, Aspergillus Spp.
Regulation 866.3040
0510(k)s in 12 months (4 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in NOM
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad | 3 | 0 |
| Bio Rad Laboratories, Inc. | 0 | 2 |
| Pearl Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2025 | K243496 | MycoMEIA Aspergillus Assay Pearl Diagnostics, Inc. | NOM |
| Jan 13, 2011 | K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 Bio-Rad | NOM |
| Jun 2, 2006 | K060641 | PLATELIA ASPERGILLUS EIA, MODEL 62793 Bio-Rad | NOM |
| May 16, 2003 | K023857 | PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 Bio-Rad | NOM |
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