510(k) K840261 ยท KRZ Calibrator For Hemoglobin And Hematocrit Measurement
CAL-CHEX, A HEMATOLOGY CALIBRATOR
| Applicant | Streck Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 21, 1984 |
| Received | Jan 5, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840261
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2025 | Siemens Healthcare Diagnostics, Inc. ADVIA 120/2120/2120i SETpoint Calibrator Open, Classified |
KRZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.