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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2005 | Bio Rad Laboratories, Inc. Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics G Terminated |
NOM | K870176 |
| Jan 14, 2004 | Bio Rad Laboratories, Inc. Platelia Aspergillus EIA Terminated |
NOM | K023857 |
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