Cleared Traditional

URISCREEN

K981084 · Diatech Diagnostics,Inc. · Microbiology

Oct 1998

Decision

196d

Days

Class 1

Risk

About This 510(k) Submission

K981084 is an FDA 510(k) clearance for the URISCREEN, a Kit, Screening, Urine (Class I — General Controls, product code JXA), submitted by Diatech Diagnostics,Inc. (Beverly, US). The FDA issued a Cleared decision on October 7, 1998, 196 days after receiving the submission on March 25, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K981084 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 1998
Decision Date	October 07, 1998
Days to Decision	196 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF