C3— 510(k) K983441

Clearance details

Applicant

Abbott Laboratories

Product code

Code CZW

Device class

Class 2

Regulation

21 CFR 866.5240

Advisory panel

Immunology

Date received

1998-09-30

Decision date

1998-11-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irving, TX, US

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• Z-1987-2019 — C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 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 C3 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 K983441.