IGA— 510(k) K983359

Clearance details

Applicant

Abbott Laboratories

Product code

Code CZP

Device class

Class 2

Regulation

21 CFR 866.5510

Advisory panel

Immunology

Date received

1998-09-24

Decision date

1998-11-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irving, TX, US

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• Z-1988-2019 — Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A in the sample.Class II·Terminated·Abbott Laboratories, Inc·20180516

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983359.