510(k) K142336 ยท CGA Glucose Oxidase, Glucose
GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
| Applicant | Arkray Factory, Inc., Koka-Shi, JP |
| Decision | Substantially Equivalent, Sep 17, 2014 |
| Received | Aug 21, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142336
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.