510(k) K130255 ยท PDJ Hemoglobin A1c Test System
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Feb 28, 2014 |
| Received | Feb 1, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130255
| 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 |
| Jun 9, 2022 | Abbott Laboratories REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL Open, Classified |
PDJ | None listed |
| Oct 24, 2014 | Abbott Laboratories HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to ly Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.