510(k) K962028 ยท GNA Antisera, All Types, Escherichia Coli
WELLCOLEX E-COLI OI57 ZC60
| Applicant | Murex Diagnostics, Inc., Norcross GA, US |
| Decision | Substantially Equivalent, Nov 1, 1996 |
| Received | May 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962028
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.