510(k) K971663 ยท GMZ Antigens, All Types, Escherichia Coli
WELLCOLEX E.COLI O157:H7
| Applicant | Murex Biotech , Ltd., Dartford,Kent, GB |
| Decision | Substantially Equivalent, Dec 30, 1997 |
| Received | May 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971663
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.