IGM— 510(k) K983132

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K983132 for IGM, Substantially Equivalent on 1998-11-04. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1998-09-08
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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Recalls naming K983132

K-number listed on FDA's recall record

Z-1990-2019 — Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M 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 M 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 K983132.

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