510(k) K970695 ยท MOI System, Test, Immunological, Antigen, Tumor
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
| Applicant | Chiron Diagnostics Corp., Alameda CA, US |
| Decision | Substantially Equivalent, Aug 8, 1997 |
| Received | Feb 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970695
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.