510(k) K223090 ยท CGA Glucose Oxidase, Glucose
GEM Premier ChemSTAT
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Jan 27, 2023 |
| Received | Sep 30, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223090
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.