APOB— 510(k) K983281

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K983281 for APOB, Substantially Equivalent on 1999-01-26. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DFC
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 1998-09-18
Decision date: 1999-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K983281

K-number listed on FDA's recall record

Z-1994-2019 — Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B 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 K983281.

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