510(k) K081719 ยท GKR System, Hemoglobin, Automated
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
| Applicant | Stanbio Laboratory, Boerne TX, US |
| Decision | Substantially Equivalent, Jul 18, 2008 |
| Received | Jun 18, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081719
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2018 | Stanbio Laboratory, LP Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany. Terminated |
GKR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.