510(k) K972156 ยท GMZ Antigens, All Types, Escherichia Coli
QUIX RAPID E. COLI O157 STRIP TEST
| Applicant | Guardian Scientific, Corp., Columbia MD, US |
| Decision | Substantially Equivalent, Oct 16, 1997 |
| Received | Jun 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972156
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.