Cleared Traditional

STAPHAUREX PLUS(TM)

K945538 · Murex Diagnostics Limitd · Microbiology

Jun 1995

Decision

199d

Days

Class 1

Risk

About This 510(k) Submission

K945538 is an FDA 510(k) clearance for the STAPHAUREX PLUS(TM), a Kit, Screening, Staphylococcus Aureus (Class I — General Controls, product code JWX), submitted by Murex Diagnostics Limitd (England, DE). The FDA issued a Cleared decision on June 1, 1995, 199 days after receiving the submission on November 14, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K945538 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 1994
Decision Date	June 01, 1995
Days to Decision	199 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF