Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls— 510(k) K140654

Clearance details

Applicant

Abbott Laboratories

Product code

Code PDJ

Device class

Class 2

Regulation

21 CFR 862.1373

Advisory panel

Clinical Chemistry

Date received

2014-03-14

Decision date

2015-05-22

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-1688-2020 — "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemoglobin A1c assay.Class II·Terminated·Abbott Laboratories·20190522

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140654.