510(k) K902892 ยท KRZ Calibrator For Hemoglobin And Hematocrit Measurement
CELL-DYN CALIBRATOR
| Applicant | Unipath , Ltd., Mountain View CA, US |
| Decision | Substantially Equivalent, Sep 10, 1990 |
| Received | Jul 2, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902892
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2006 | Abbott Laboratories Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems.
Model numbers: 99120-01 Terminated |
KRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.