510(k) K002621 ยท CGA Glucose Oxidase, Glucose
GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Apex BioTechnology Corp., Plymouth MN, US |
| Decision | Substantially Equivalent, Jan 22, 2001 |
| Received | Aug 23, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002621
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2008 | ARKRAY USA INC. Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard, Minneapolis, MN 55439 USA. Made in Taiwan. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.