510(k) K973457 ยท GMZ Antigens, All Types, Escherichia Coli
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
| Applicant | Shared Systems, Inc., Martinez GA, US |
| Decision | Substantially Equivalent, Jan 2, 1998 |
| Received | Sep 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973457
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.