Cleared Traditional

CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR

K133519 · Carolina Liquid Chemistries Corp. · Chemistry

May 2014

Decision

182d

Days

Class 1

Risk

About This 510(k) Submission

K133519 is an FDA 510(k) clearance for the CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Carolina Liquid Chemistries Corp. (Winston-Salem, US). The FDA issued a Cleared decision on May 16, 2014, 182 days after receiving the submission on November 15, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number	K133519 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 15, 2013
Decision Date	May 16, 2014
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2160