CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC— 510(k) K121823

Name: FDA 510(k) clearance K121823
Creator: U.S. Food and Drug Administration
Published: 2013-03-27

Substantially Equivalent

Wescor, Inc.

FDA 510(k) clearance K121823 for CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC, Substantially Equivalent on 2013-03-27. Applicant: Wescor, Inc.. Device class: 2.

Clearance details

Applicant: Wescor, Inc.
Product code: Code JFS
Device class: Class 2
Regulation: 21 CFR 862.1170
Advisory panel: Clinical Chemistry
Date received: 2012-06-21
Decision date: 2013-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Logan, UT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Wescor, Inc.

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