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510(k) K121823

Device
CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
Applicant
WESCOR, INC.
510(k) number
K121823
Product code
JFS  
Decision
Substantially Equivalent (SESE)
Decision date
2013-03-27
Date received
2012-06-21
Regulation
862.1170
Classification name
Coulometric, Chloride
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAWN T PERDUE
Address
370 W 1700 S Logan UT US 84321 84321

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JFS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K923598REDI-CHECK PHOTMETER Q.A.Awareness Technology, Inc.1992-10-14
K873127CHLORIDE REAGENT KITA-Kem, Inc.1987-10-23
K830217REAGENTS CORNING CHLORIDE METER FORFisher Scientific Co., LLC1983-02-18
K823106RERMCO TEST CHLORIDE REAGENTFermco Biochemics, Inc.1982-11-16
K820411LIQUIZYME CHLORIDE REAGENTAmerican Research Products Co.1982-03-08
K811319CHLORIDE REAGENT KITChem-Elec, Inc.1981-08-13
K811701CHLORIDE/CARBON DIOXIDE RATE REAGENTChem-Elec, Inc.1981-07-01
K810550SILVER ANODENobel Scientific Industries, Inc.1981-04-08
K810615CORNING 925 CHLORIDE METERCorning Medical & Scientific1981-03-17
K802080BAKER DIAG. ULTRARATE CHLORIDE KITJ.T. Baker Chemical Co.1980-10-10
K800585NSI CHLORIDE REAGENT KITNobel Scientific Industries, Inc.1980-04-02
K800217CHLORIDE REAGENT, CUP & CLEANERFisher Scientific Co., LLC1980-02-26
K791690CHOLORDE REAGENTHi Chem, Inc.1979-09-17
K790045REAGENT KIT, CHLORIDE/CARBON DIOXIDEJ.T. Baker Chemical Co.1979-02-22
K781275CHLORIDE/CARBON DIOXIDE REAGENT SETNobel Scientific Industries, Inc.1978-08-31

Legacy Summary#

summary

FDA Review#

Decision Summary