510(k) K021484 ยท LCP Assay, Glycosylated Hemoglobin
HEMOGLOBIN A1C CONTROL
| Applicant | Canterbury Scientific , Ltd., Christchurch, NZ |
| Decision | Substantially Equivalent, Jun 14, 2002 |
| Received | May 8, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021484
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2018 | Tosoh Bioscience Inc Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.