Igx Plex Celiac Qualitative Assay

FDA 510(k) K102490 · Sqi Diagnostics Systems

Substantially Equivalent

510(k) numberK102490

Submission

Device name
Igx Plex Celiac Qualitative Assay
Applicant
Sqi Diagnostics Systems
Toronto, On, CA
Received
August 31, 2010
Decision date
June 2, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MVM – Autoantibodies, Endomysial(Tissue Transglutaminase)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5660
Specialty
Immunology

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K140691Ig_Plex Celiac DGP PanelMVM · Traditional Sqi Diagnostics Systems, Inc.11/06/2014SE
K123713Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional Immco Diagnostics, Inc.10/25/2013SE
K130053Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga…MVM · Traditional Bio-Rad Laboratories, Inc.09/19/2013SE
K101644Quanta Flash H-Ttg IggMVM · Traditional Inova Diagnostics, Inc.03/23/2011SE
K102964Eu-Ttg Iga and Eu-Ttg IggMVM · Traditional Grifols USA, Inc.03/07/2011SE
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More from Inova Diagnostics, Inc.

510(k)DeviceDecision
K140691Ig_Plex Celiac DGP PanelMVM · Traditional 11/06/2014SE
K083080Igx Plex Rheumatoid Arthritis (Ra) Assay and Sqidworks Diagnostics PlatformDHR · Traditional 10/29/2009SE

Questions and answers

When was Igx Plex Celiac Qualitative Assay cleared by the FDA?

Igx Plex Celiac Qualitative Assay (K102490) received a 510(k) decision of Substantially Equivalent on June 2, 2011, 275 days after the submission was received.

What is the product code of K102490?

The FDA product code is MVM – Autoantibodies, Endomysial(Tissue Transglutaminase), a Class II (moderate risk) device regulated under 21 CFR 866.5660.