510(k) K002350 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
REFACTO LABORATORY STANDARD
| Applicant | The Genetics Institute, Cambridge MA, US |
| Decision | Substantially Equivalent, Oct 5, 2000 |
| Received | Aug 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002350
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.