Cleared Traditional

RUBALEX, MODIFICATION

K912391 · Orion Corp. · Microbiology
May 1992
Decision
346d
Days
Class 2
Risk

About This 510(k) Submission

K912391 is an FDA 510(k) clearance for the RUBALEX, MODIFICATION, a Latex Agglutination Assay, Rubella (Class II — Special Controls, product code LQN), submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on May 4, 1992, 346 days after receiving the submission on May 24, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K912391 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1991
Decision Date May 04, 1992
Days to Decision 346 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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