FDA Registration Active 🇺🇸 United States

Alinity c Processing Module (LN 03R6701)

Reg #: 1415939 · FEI: 1415939 · Expires 2025
Products
2
Proprietary Names
5
Establishment Types
1
Classifications
2

Registration Details

Registration Name
ABBOTT LABORATORIES
Registration Number
1415939
FEI Number
1415939
Status
Active
Expiry Year
2025
Initial Importer
No
Address
100 ABBOTT PARK RD.
City
Abbott Park
State
IL
ZIP
60064
Country
US

Regulatory Submissions

510(k) Number
K170316

Owner / Operator

Firm Name
ABBOTT LABORATORIES
Operator Number
1415939
Address
100 ABBOTT PARK RD., D-03Q3, AP52-1
City
Abbott Park
State
IL
Postal Code
60064
Country
US

Products

Device Name Product Code
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
Hexokinase, Glucose CFR

Proprietary Names

Alinity c Processing Module (LN 03R6701) Alinity c Glucose Reagent Kit (LN 07P5520, 07P5530) Alinity c System Alinity ci-series System Control Module (LN 03R7001) Alinity c System Accessories

Establishment Types

Manufacture Medical Device