IGG— 510(k) K983221

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K983221 for IGG, Substantially Equivalent on 1998-11-04. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1998-09-14
Decision date: 1998-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD2000-01-18
K993281 — K-ASSAY IGG1999-11-09

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Recalls naming K983221

K-number listed on FDA's recall record

Z-1989-2019 — Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G 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 G 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 K983221.

Data sourced from openFDA. This site is unofficial and independent of the FDA.