Cleared Traditional

MUREX RUB-EX

K954920 · Murex Diagnostics, Inc. · Microbiology

Aug 1996

Decision

300d

Days

Class 2

Risk

About This 510(k) Submission

K954920 is an FDA 510(k) clearance for the MUREX RUB-EX, a Latex Agglutination Assay, Rubella (Class II — Special Controls, product code LQN), submitted by Murex Diagnostics, Inc. (Norcross, US). The FDA issued a Cleared decision on August 21, 1996, 300 days after receiving the submission on October 26, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number	K954920 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 26, 1995
Decision Date	August 21, 1996
Days to Decision	300 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF