Cleared Traditional

NOVA LITE ENDOMYSIAL

K980312 · Inova Diagnostics, Inc. · Immunology

Apr 1998

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K980312 is an FDA 510(k) clearance for the NOVA LITE ENDOMYSIAL, a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBL), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 2, 1998, 65 days after receiving the submission on January 27, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K980312 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 1998
Decision Date	April 02, 1998
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5660