510(k) K071799 ยท GNA Antisera, All Types, Escherichia Coli
MODIFICATION TO BIOSTAR OIA SHIGATOX
| Applicant | Iverness Medical Professional Diagnostics, Louisville CO, US |
| Decision | Substantially Equivalent, Oct 2, 2007 |
| Received | Jul 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071799
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.