510(k) K897136 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Feb 5, 1990 |
| Received | Dec 27, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897136
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.