HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS— 510(k) K130255

Clearance details

Applicant

Abbott Laboratories

Product code

Code PDJ

Device class

Class 2

Regulation

21 CFR 862.1373

Advisory panel

Clinical Chemistry

Date received

2013-02-01

Decision date

2014-02-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Abbott Park, IL, US

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• Z-1454-2022 — 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 mLClass II·Ongoing·Abbott Laboratories·20220609
• Z-1455-2022 — 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 mLClass II·Ongoing·Abbott Laboratories·20220609
• Z-0135-2015 — 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 lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.Class II·Terminated·Abbott Laboratories·20140430

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130255.