Cleared Traditional

CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC

K121823 · Wescor, Inc. · Chemistry

Mar 2013

Decision

279d

Days

Class 2

Risk

About This 510(k) Submission

K121823 is an FDA 510(k) clearance for the CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC, a Coulometric, Chloride (Class II — Special Controls, product code JFS), submitted by Wescor, Inc. (Logan, US). The FDA issued a Cleared decision on March 27, 2013, 279 days after receiving the submission on June 21, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number	K121823 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2012
Decision Date	March 27, 2013
Days to Decision	279 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF