510(k) K110637 ยท LFR Glucose Dehydrogenase, Glucose
ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Cilag GmbH International, Zug, CH |
| Decision | Substantially Equivalent, Sep 7, 2011 |
| Received | Mar 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110637
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2012 | Lifescan Inc OneTouch Verio IQ Blood Glucose Monitoring System Kit;
One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit;
One Touch Verio IQ Blood Glucose Monitoring Warranty Kit.
Distributed Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.