510(k) K121842 ยท LCP Assay, Glycosylated Hemoglobin
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Dec 12, 2012 |
| Received | Jun 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2019 | Abbott Laboratories ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (H Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.