Cleared Traditional

OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)

K011043 · Osmetech · Microbiology

Nov 2001

Decision

239d

Days

Class 1

Risk

About This 510(k) Submission

K011043 is an FDA 510(k) clearance for the OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI), a Kit, Screening, Urine (Class I — General Controls, product code JXA), submitted by Osmetech (Crewe, GB). The FDA issued a Cleared decision on November 30, 2001, 239 days after receiving the submission on April 5, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K011043 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2001
Decision Date	November 30, 2001
Days to Decision	239 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF