DISTAT ANTI-SCL-70 KIT— 510(k) K912291

Clearance details

Applicant

Shield Diagnostics, Ltd.

Product code

Code LKJ

Device class

Class 2

Regulation

21 CFR 866.5100

Advisory panel

Immunology

Date received

1991-05-23

Decision date

1991-07-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Dundee, GB

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• Z-2922-2018 — is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process.Class III·Terminated·Euro Diagnostica AB·20161021

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K912291.