Diastat Anti-Ro (Ss-a)

• • Terminated Z-2919-2018 FDA Class III ·initiated 21 Oct 2016

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

510(k) Number

K905194 ↗

FDA Product Code

LKO

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Diastat ENA Single Well Screen Kit

  Class II

  FDA 510(k) K944505 Active Cleared 21 Nov 1994

• Diastat Anti-Centromere Kit

  Class II

  FDA 510(k) K932877 Active Cleared 15 Oct 1993

• Shield Von Willebrand Factor Activity (Elisa) Assay

  Class II

  FDA 510(k) K962825 Active Cleared 15 Nov 1996

• Quantase Phenylalanine Assay

  Class II

  FDA 510(k) K961515 Active Cleared 12 Jun 1996

• Diastat Total Anti-Cardiolipin Kit

  Class II

  FDA 510(k) K923886 Active Cleared 25 Sep 1992

• Diastat Anti-La (Ss-B)

  Class II

  FDA 510(k) K905193 Active Cleared 13 Dec 1990

See all devices from Shield Diagnostics, Ltd. →