510(k) K853776 ยท JPK Mixture, Hematology Quality Control
MSI-HB HEMOGLOBIN CONTROL
| Applicant | Medical Specialties, Inc., South Plainfield NJ, US |
| Decision | Substantially Equivalent, Sep 19, 1985 |
| Received | Sep 10, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853776
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2021 | Medline Industries Inc RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks t Terminated |
JPK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.