510(k) K904247 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
FREE PROTEIN S REAGENT CAT. NO. 5363
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jan 18, 1991 |
| Received | Sep 14, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904247
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.