Cleared Traditional

IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT

K050352 · Ameritek Research, LLC · Chemistry

Sep 2005

Decision

202d

Days

Class 1

Risk

About This 510(k) Submission

K050352 is an FDA 510(k) clearance for the IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Ameritek Research, LLC (Mill Creek, US). The FDA issued a Cleared decision on September 1, 2005, 202 days after receiving the submission on February 11, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K050352 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2005
Decision Date	September 01, 2005
Days to Decision	202 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement