Cleared Traditional

K972676 - URINE SCREENING DEVICE
(FDA 510(k) Clearance)

K972676 · Combact Diagnostic Systems , Ltd. · Microbiology

Feb 1998

Decision

222d

Days

Class 1

Risk

K972676 is an FDA 510(k) clearance for the URINE SCREENING DEVICE, a Kit, Screening, Urine (Class I — General Controls, product code JXA), submitted by Combact Diagnostic Systems , Ltd. (Rockville, US). The FDA issued a Cleared decision on February 23, 1998, 222 days after receiving the submission on July 16, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K972676 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 1997
Decision Date	February 23, 1998
Days to Decision	222 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF