Cleared Traditional

COLORSLIDER RUBELLA

K952544 · Seradyn, Inc. · Microbiology
Jan 1996
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K952544 is an FDA 510(k) clearance for the COLORSLIDER RUBELLA, a Latex Agglutination Assay, Rubella (Class II — Special Controls, product code LQN), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 17, 1996, 229 days after receiving the submission on June 2, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K952544 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1995
Decision Date January 17, 1996
Days to Decision 229 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LQN — Latex Agglutination Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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