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FDA 510(k)

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

K-Number: K121823 · 2013-03-27

ApplicantWescor, Inc.
Decision Date2013-03-27
Product CodeJFS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC is the device name listed in this FDA 510(k) record. The listed applicant is Wescor, Inc.. It received FDA 510(k) clearance on 2013-03-27 under 510(k) number K121823. The device is classified under product code JFS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC?

CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC is a medical device that received FDA 510(k) clearance on 2013-03-27. The listed applicant is Wescor, Inc.. The 510(k) number is K121823.

When did CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC receive FDA 510(k) clearance?

CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC received FDA 510(k) clearance on 2013-03-27, under 510(k) number K121823.

Who is the listed applicant for CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC?

The FDA 510(k) record lists Wescor, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC?

The FDA product code for CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC is JFS.

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Other records listing Wescor, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K010031NANODUCT NEONATAL SWEAT ANALYSIS SYSTEMK863395WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZERK881592WESCOR MODEL 7300 AEROSPRAY GRAM STAINERK881512WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAYK880544WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAYK853973WESCOR MODEL 3700 WEBSTER SWEAT INDUCER

View all 13 devices →

Related Devices (Code: JFS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K923598REDI-CHECK PHOTMETER Q.A.Awareness Technology, Inc.K873127CHLORIDE REAGENT KITA-Kem, Inc.K830217REAGENTS CORNING CHLORIDE METER FORFisher Scientific Co., LLCK823106RERMCO TEST CHLORIDE REAGENTFermco Biochemics, Inc.K820411LIQUIZYME CHLORIDE REAGENTAmerican Research Products Co.K811319CHLORIDE REAGENT KITChem-Elec, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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