510(k) K120448 ยท CGA Glucose Oxidase, Glucose
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
| Applicant | Apex BioTechnology Corp., Hsinchu, TW |
| Decision | Substantially Equivalent, Apr 6, 2012 |
| Received | Feb 14, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2019 | Medline Industries Inc EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil pouches per box, 12 boxes per case. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.