510(k) K003346 ยท CGA Glucose Oxidase, Glucose
RANDOX GLUCOSE (GOD/PAP)
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, GB |
| Decision | Substantially Equivalent, Mar 15, 2001 |
| Received | Oct 25, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003346
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.