Distat Anti-Scl-70 Kit

• • Terminated Z-2922-2018 FDA Class III ·initiated 21 Oct 2016

  Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

510(k) Number

K912291 ↗

FDA Product Code

LKJ

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Diastat Anti-La (Ss-B)

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  FDA 510(k) K905193 Active Cleared 13 Dec 1990

See all devices from Shield Diagnostics, Ltd. →