510(k) K944421 ยท GMZ Antigens, All Types, Escherichia Coli
E.COLI 0157 LATEX TEST
| Applicant | Pro-Lab Diagnostics, Ontario, CA |
| Decision | Substantially Equivalent, Dec 15, 1994 |
| Received | Aug 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944421
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.