Atlas FDA

JFS

19 FDA 510(k) clearances · Product code

38 daysmedian time to decision
93 days90th percentile
19clearances measured

FDA profile

Official device name
Coulometric, Chloride
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1170
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC (K121823)Wescor, Inc.2013-03-27
REDI-CHECK PHOTMETER Q.A. (K923598)Awareness Technology, Inc.1992-10-14
CHLORIDE REAGENT KIT (K873127)A-Kem, Inc.1987-10-23
REAGENTS CORNING CHLORIDE METER FOR (K830217)Fisher Scientific Co., LLC1983-02-18
RERMCO TEST CHLORIDE REAGENT (K823106)Fermco Biochemics, Inc.1982-11-16
LIQUIZYME CHLORIDE REAGENT (K820411)American Research Products Co.1982-03-08
CHLORIDE REAGENT KIT (K811319)Chem-Elec, Inc.1981-08-13
CHLORIDE/CARBON DIOXIDE RATE REAGENT (K811701)Chem-Elec, Inc.1981-07-01
SILVER ANODE (K810550)Nobel Scientific Industries, Inc.1981-04-08
CORNING 925 CHLORIDE METER (K810615)Corning Medical & Scientific1981-03-17
BAKER DIAG. ULTRARATE CHLORIDE KIT (K802080)J.T. Baker Chemical Co.1980-10-10
NSI CHLORIDE REAGENT KIT (K800585)Nobel Scientific Industries, Inc.1980-04-02
CHLORIDE REAGENT, CUP & CLEANER (K800217)Fisher Scientific Co., LLC1980-02-26
CHOLORDE REAGENT (K791690)Hi Chem, Inc.1979-09-17
REAGENT KIT, CHLORIDE/CARBON DIOXIDE (K790045)J.T. Baker Chemical Co.1979-02-22
CHLORIDE/CARBON DIOXIDE REAGENT SET (K781275)Nobel Scientific Industries, Inc.1978-08-31
CHEMLAR (K781132)Hi Chem, Inc.1978-08-10
CHLORIDE (K771832)Gamma Enterprises, Inc.1977-11-22
REAGENT, CHLORIDOMETER ACID (K760394)Bulcher Instruments1976-11-01

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Every clearance here is in the API, with alerts when new ones post.