510(k) K170901 ยท CIX Bromcresol Green Dye-Binding, Albumin
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
| Applicant | Biosystems S.A., Barcelona, ES |
| Decision | Substantially Equivalent, Apr 13, 2018 |
| Received | Mar 27, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170901
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.