510(k) K002134 ยท CGA Glucose Oxidase, Glucose
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Selfcare, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Aug 7, 2000 |
| Received | Jul 14, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002134
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.