510(k) K151639 ยท CGA Glucose Oxidase, Glucose
ABL80 FLEX and ABL80 FLEX CO-OX
| Applicant | Sendx Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 7, 2015 |
| Received | Jun 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151639
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.