Cleared Traditional

K000116 - QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
(FDA 510(k) Clearance)

K000116 · Consolidated Technologies, Inc. · Chemistry

Feb 2000

Decision

32d

Days

Class 1

Risk

K000116 is an FDA 510(k) clearance for the QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY).

Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on February 15, 2000, 32 days after receiving the submission on January 14, 2000.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K000116 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 2000
Decision Date	February 15, 2000
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement