510(k) K041230 ยท LFR Glucose Dehydrogenase, Glucose
CLINICAL LABORATORY ANALYZING SYSTEM
| Applicant | Hemocue, Inc., Potomac MD, US |
| Decision | Substantially Equivalent, May 20, 2004 |
| Received | May 10, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041230
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2011 | Hemo Cue, Inc. HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative determination of blood glucose level. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.