510(k) K896174 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Mar 15, 1990 |
| Received | Oct 25, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896174
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.