Cleared Traditional

RIT LIVER, KIDNEY, STOMACH IFA KIT

K955431 · The Binding Site, Ltd. · Immunology

Apr 1996

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K955431 is an FDA 510(k) clearance for the RIT LIVER, KIDNEY, STOMACH IFA KIT, a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBL), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on April 23, 1996, 147 days after receiving the submission on November 28, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K955431 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 1995
Decision Date	April 23, 1996
Days to Decision	147 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