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JFS — Coulometric, Chloride Class II

FDA Device Classification

Classification Details

Product Code
JFS
Device Class
Class II
Regulation Number
862.1170
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K121823wescorCLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORMarch 27, 2013
K923598awareness technologyREDI-CHECK PHOTMETER Q.A.October 14, 1992
K873127a-kemCHLORIDE REAGENT KITOctober 23, 1987
K830217fisher scientific coREAGENTS CORNING CHLORIDE METER FORFebruary 18, 1983
K823106fermco biochemicsRERMCO TEST CHLORIDE REAGENTNovember 16, 1982
K820411american research productsLIQUIZYME CHLORIDE REAGENTMarch 8, 1982
K811319chem-elecCHLORIDE REAGENT KITAugust 13, 1981
K811701chem-elecCHLORIDE/CARBON DIOXIDE RATE REAGENTJuly 1, 1981
K810550nobel scientific industriesSILVER ANODEApril 8, 1981
K810615corning medical and scientificCORNING 925 CHLORIDE METERMarch 17, 1981
K802080j.t. baker chemicalBAKER DIAG. ULTRARATE CHLORIDE KITOctober 10, 1980
K800585nobel scientific industriesNSI CHLORIDE REAGENT KITApril 2, 1980
K800217fisher scientific coCHLORIDE REAGENT, CUP & CLEANERFebruary 26, 1980
K791690hi chemCHOLORDE REAGENTSeptember 17, 1979
K790045j.t. baker chemicalREAGENT KIT, CHLORIDE/CARBON DIOXIDEFebruary 22, 1979
K781275nobel scientific industriesCHLORIDE/CARBON DIOXIDE REAGENT SETAugust 31, 1978
K781132hi chemCHEMLARAugust 10, 1978
K771832gamma enterprisesCHLORIDENovember 22, 1977
K760394bulcher instrumentsREAGENT, CHLORIDOMETER ACIDNovember 1, 1976