Cleared Traditional

QUANTA LITE M2 EP (MIT3) ELISA

K052262 · Inova Diagnostics, Inc. · Immunology

Oct 2005

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K052262 is an FDA 510(k) clearance for the QUANTA LITE M2 EP (MIT3) ELISA, a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 27, 2005, 69 days after receiving the submission on August 19, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number	K052262 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2005
Decision Date	October 27, 2005
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5090