Cleared Traditional

LIQUISPEX(TM) URINE ETHANOL CONTROL

K946144 · Clinical Controls, Inc. · Toxicology
Feb 1995
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K946144 is an FDA 510(k) clearance for the LIQUISPEX(TM) URINE ETHANOL CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on February 8, 1995, 54 days after receiving the submission on December 16, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K946144 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1994
Decision Date February 08, 1995
Days to Decision 54 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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