FDA Registration Active 🇺🇸 United States

ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS

Reg #: 1717966 · FEI: 1717966 · Expires 2025
Products
2
Proprietary Names
4
Establishment Types
2
Classifications
2

Registration Details

Registration Name
ELITechGroup Inc
Registration Number
1717966
FEI Number
1717966
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
370 West 1700 South
City
LOGAN
State
UT
ZIP
84321
Country
US

Regulatory Submissions

510(k) Number
K121823

Owner / Operator

Firm Name
ELITechGroup Inc.
Operator Number
1717966
Address
370 West 1700 South
City
Logan
State
UT
Postal Code
84321
Country
US

Products

Device Name Product Code
Coulometric, Chloride JFS
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

Proprietary Names

ChloroChek® Reagent Set, 37x10mL BS + 1x30mL GS Sweat Controls, L1, L2, L3 12 ea., 36x0.75mL ChloroChek® Chloridometer® Sweat Chloride Analyzer, Model 3400 ChloroChek® Standard Solution, 100 mmol/L, 10x1mL

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device