Cleared Traditional

K992576 - URINE CHEMISTRY CONTROL, LEVEL 1
(FDA 510(k) Clearance)

K992576 · Consolidated Technologies, Inc. · Chemistry

Sep 1999

Decision

32d

Days

Class 1

Risk

K992576 is an FDA 510(k) clearance for the URINE CHEMISTRY CONTROL, LEVEL 1, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on September 3, 1999, 32 days after receiving the submission on August 2, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K992576 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 1999
Decision Date	September 03, 1999
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF