510(k) K120497 ยท LCP Assay, Glycosylated Hemoglobin
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
| Applicant | Medica Corp., Bedford MA, US |
| Decision | Substantially Equivalent, May 14, 2012 |
| Received | Feb 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2017 | Medica Corporation EasyCAL HbA1c Calibrator; REF 10658
Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet. Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.