510(k) K183440 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
CRYOcheck FVIII Inhibitor Kit
| Applicant | Precision Biologic, Inc., Darmouth, CA |
| Decision | Substantially Equivalent, Mar 12, 2019 |
| Received | Dec 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183440
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.