510(k) K023857 ยท NOM Antigen, Galactomannan, Aspergillus Spp.
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794
| Applicant | Bio-Rad, Redmond WA, US |
| Decision | Substantially Equivalent, May 16, 2003 |
| Received | Nov 20, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023857
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2004 | Bio Rad Laboratories, Inc. Platelia Aspergillus EIA Terminated |
NOM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.