510(k) K140654 ยท PDJ Hemoglobin A1c Test System
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, May 22, 2015 |
| Received | Mar 14, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140654
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2022 | Abbott Laboratories REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL Open, Classified |
PDJ | None listed |
| May 22, 2019 | Abbott Laboratories "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay. Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.