510(k) K032203 ยท GKR System, Hemoglobin, Automated
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
| Applicant | Hemocue, Inc., Potomac MD, US |
| Decision | Substantially Equivalent, Aug 25, 2003 |
| Received | Jul 18, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032203
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2013 | HemoCue AB HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden Terminated |
GKR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.