510(k) K041234 ยท GKR System, Hemoglobin, Automated
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
| Applicant | Hemocue, Inc., Potomac MD, US |
| Decision | Substantially Equivalent, Jun 10, 2004 |
| Received | May 10, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041234
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2011 | Hemo Cue, Inc. HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination. Terminated |
GKR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.